Cup with crosslinked polymer layer modular pegs

ABSTRACT

This invention related to a method of forming a polymer component and comprises blending polymer particles with antioxidant to form a mixture in which the antioxidant coats the polymer particles, irradiating the polymer particles to cross-link the polymer particles therein and forming the irradiated mixture into a consolidated component. The invention also relates to a method of forming an articular surface for a prosthesis and a prosthesis having a polymer articular bearing surface wherein at least one predetermined portion of the bearing surface is provided with cross-linked polymer bonds.

FIELD OF THE INVENTION

This invention relates to a method of forming a polymer component.Particularly, but not exclusively, the invention relates to a method offorming a polymer component for a prosthesis such as an acetabular cupprosthesis for use in hip resurfacing.

BACKGROUND TO THE INVENTION

Hip resurfacing is commonly performed using acetabular cups and femoralcomponents which are made from solid metal. However, it has beenestimated that approximately 1% of patients who undergo suchmetal-on-metal hip resurfacing have a pseudo-tumour in the form of asoft tissue mass or large symptomatic effusion within 5 years. Thesymptoms of these pseudo-tumours include discomfort, spontaneousdislocation, nerve palsy, a noticeable mass and a rash, while the commonhistological features are extensive necrosis and lymphocyticinfiltration. As a consequence, many patients require revision surgeryfollowed by conventional total hip replacement.

Whilst the cause of these pseudo-tumours is currently unconfirmed, ithas been observed that they occur in situations of high bearing wear.This could be caused by poor wearing metal as a result of non-optimalheat treatment during processing or due to component misalignment, whichmay either result from the surgeon mal-positioning one or more of thecomponents or from an underlying bony misalignment of the skeleton (e.g.developmental dysplasia of the hip). Edge wear of the acetabularcomponent has also been observed along with excessive wear of thefemoral component due to impingement.

It is believed that the pseudo-tumours may, in fact, be due to a toxicreaction to an excess of particulate metal wear debris or metal ions or,perhaps, a hypersensitivity reaction to a normal amount of metal weardebris. There is therefore a concern that, with time, the incidence ofthese pseudo-tumours may increase.

Other materials have been considered for use in hip resurfacing. Forexample, a metal outer cup shell has been combined with a polymer (e.g.conventional non cross-linked polyethylene) inner cup liner. However, inthese instances an even higher failure rate is encountered because wearof the bearing surface leads to early loosening of the joint and theproduction of large quantities of polymer debris. This results inosteolysis of the acetabulum and femur making revision surgery difficultdue to the loss of bone stock.

Commonly, acetabular cups are configured for press-fit fixation (e.g. byforcing a 50 mm outer diameter component into a 48 mm diameter hole).This can result in considerable deformation (e.g. in the range of 100microns to over 350 microns), even where thick metal shells areemployed, and so there is a risk that the cup will grip the femoralcomponent leading to early acetabular component breakout. Alternativefixation features, such as large projecting pegs, are thereforesometimes employed. To aid fixation of these components, the externalsurface of the cup is often provided with a porous coating (e.g. byplasma spraying titanium particles) to encourage bone in-growth.However, such a coating only tends to provide limited contact betweenthe bone and the metal coating leading to poor grip. In addition, thetitanium particles can easily become dislodged, such that they thenserve as abrasive debris.

It is therefore an aim of the present invention to provide a method offorming a polymer component (e.g. for a prosthesis such as an acetabularcup prosthesis), which helps to ameliorate some of all of theafore-mentioned problems.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided amethod of forming a polymer component comprising:

-   -   blending polymer particles with antioxidant to form a mixture in        which the antioxidant coats the polymer particles;    -   irradiating the polymer particles to cross-link molecules        therein; and forming the irradiated mixture into a consolidated        component.

The step of blending the polymer particles with antioxidant may beperformed before, during or after the step of irradiating the polymerparticles to cross-link the molecules therein.

It will be understood that the step of blending the polymer particleswith antioxidant will occur before the irradiated mixture is formed intoa consolidated component.

The method may further comprise the step of reducing or substantiallyeliminating the presence of oxygen in or between the polymer particles.This step may be performed prior to or during irradiation and/or whenforming the irradiated mixture into a consolidated component.

The cross-linking of polymer material (e.g. polyethylene) has previouslybeen performed by irradiating bar stock or a finished product afterconsolidation. Free radicals are an unwanted by-product of this processand commonly re-melting of the cross-linked polymer is performed toeliminate the free radicals. However, the mechanical properties of thepolymer have been found to deteriorate as a result of re-melting.

It is also known to irradiate polythene resin (powder, particles orflakes) in air or a reduced oxygen atmosphere so as to minimise freeradical formation during cross-linking to thereby try to eliminate theneed for re-melting. After the polythene resin has been cross-linked thematerial is consolidated (e.g. by compression moulding) and this stepfurther helps to eliminate free radicals due to the application of heatand pressure. The problem with this approach, however, is that the verylarge surface area of the polyethylene resin permits oxidation of thematerial during or after irradiation, even when irradiation is carriedout in a reduced oxygen atmosphere. It is believed that one reason forthis problem of oxidation during irradiation or during subsequentmoulding of the irradiated particles is that approximately 5% oxygen canbe contained within the polymer (e.g. polyethylene) particles (e.g. inthe interstices thereof). The free radicals produced during irradiationcan thus combine with the oxygen contained in the polymer particles. Theresulting oxidized polymer is of a poor quality since it will besusceptible to severe wear and fracture due to mechanical weakening.

Embodiments of the present invention solve the problems outlined aboveby initially reducing or eliminating the oxygen in the polymerparticles, prior to irradiation. This may be done by storing the polymerparticles in a container providing an inert gas atmosphere (e.g.nitrogen) for a period of time (e.g. hours, days or weeks). The inertgas in the container with the polymer particles may be changed on aplurality of occasions to assist oxygen diffusion from the polymerparticles. Alternatively, storage of the polymer particles in a vacuummay assist the diffusion of oxygen out of the polymer particles.Although the above methods serve to reduce the oxygen concentration inthe polymer particles. it is near impossible to reduce the oxygenconcentration to zero. Since there will likely remain a finiteconcentration of oxygen in the polymer particles, it is a further objectof the invention to blend antioxidant (e.g. vitamin E) with the polymerparticles, before, during or after irradiation to prevent or reduceoxidation by combination of any remnant oxygen with free radicalsproduced as a consequence of the cross-linking irradiation. It will beunderstood that the step of blending the polymer particles withantioxidant will be performed until the antioxidant substantially coatsthe surfaces of all of the polymer particles.

The step of forming the irradiated mixture into a consolidated componentmay comprise use of direct compression moulding, ram extrusion orcompression moulding.

It is known in compression moulding or direct compression moulding tointroduce reptations in order to more completely fuse together polymerparticles (e.g. polymer powder). Typically during a moulding cycle thecompression pressure is relaxed several times. A common regimen is toapply pressure for 1 minute, then relax the compression pressure for 1minute, then apply pressure for 1 minute, this cycle being repeatedbetween 3 and 6 times. This has been found to expel air more completelyfrom between the polymer particles and to ensure that the particles aremore tightly packed together giving improved mechanical properties. Theapplicant has devised a method of applying mechanical vibrations or morepreferably ultrasound energy to the moulding apparatus in order toassist in a more complete expulsion of air from between the polymerparticles and to ensure a tighter packing of the polymer particles. Theapplicant has further devised a method for enclosing the mouldingapparatus in a chamber which is subjected to a vacuum. The object is toremove air and oxygen which has been displaced from between the polymerparticles in order to minimise the opportunity for oxidation to occur.

According to the known art, if an antioxidant blended polymer powder isconsolidated by heat and pressure (e.g. by compression moulding) theantioxidant (e.g. vitamin E) will diffuse from the surface of thepolymer powder into every molecule of the polymer under the influence ofheat from the consolidation process. In the case of polyethylene thediffusion is into the loosely formed, amorphous phase of eachpolyethylene molecules (which accounts for about 50% of eachpolyethylene molecule). The crystalline phase is much tighter packed andharder to diffuse substances into. When the antioxidant containingconsolidated polyethylene cools and is irradiated the antioxidanthinders cross-linking for the following reasons. It is the amorphousphase that is largely involved in cross-linking. Irradiation normallyresults in cross-linking by causing scissions in the polyethylenemolecular chains. These scissions have free radicals on the ends of thebroken chains. The broken ends tend to link with other surroundingmolecular chain ends or sides so producing a cross-linked structure.However, when antioxidant is present in the amorphous phase, theantioxidant neutralises the free radicals on the broken chain ends, thusinhibiting cross-linking.

With the present invention, it is the polymer particles that areirradiated rather than a consolidated component. When blending of thepolymer particles with antioxidant occurs before irradiation, then, asthe blended polymer has not been heated prior to irradiation, theantioxidant will be substantially on the surface of the polymerparticles. The irradiation will therefore cause uninhibitedcross-linking inside the polymer particles. However, on the surface ofthe polymer particles the antioxidant will prevent oxidation.

When the irradiated mixture of the present invention is consolidated,the antioxidant is allowed to diffuse into the amorphous phase of eachpolymer molecule, for example under the influence of heat. It is notedthat, when hot, antioxidants (e.g. vitamin E) are relatively inactive.It is also noted that during heating the cross-links tend to break upand when cooling starts the cross-links start to reform. Free radicalsare also eradicated during this heating and cooling phase ofconsolidation of the polymer and instead of remaining as free radicals,they are involved in further cross-linking of the polymer chains. Oncooling, the extensive cross-linking joins what were individual polymerparticles into a homogenous mass, thus eliminating fusion defects. Whenthe consolidated polymer cools to approximately 37 degrees C., theantioxidant (e.g. vitamin E) becomes fully active again, although incertain embodiments the process of heating and cooling has been found todestroy approximately 50% of the antioxidant activity.

It is the case that using the known art, whereby vitamin E is blendedwith polyethylene powder, then consolidated by heat and pressure andthen cooled to ambient temperature, vitamin E in the amorphous phaseinhibits radiation induced cross-linking of the consolidated polymer.There is therefore a delicate balance to be struck in providing enoughvitamin E to neutralise the free radicals that are produced as anunwanted by product of cross-linking, but not too high a concentrationof vitamin E to inhibit cross-linking. If the concentration of vitamin Eis too low, then all of the vitamin E may be consumed in neutralisingfree radicals produced as an unwanted by product of irradiation. In thiseventuality, no vitamin E will be available to neutralise free radicalsproduced by further irradiation (e.g. during a sterilisation process) orby stress-induced cross-link breakdown during use.

It is possible to modify the known art, by heating the consolidatedpolymer prior to and/or during irradiation so that during irradiationthe antioxidant is substantially reversibly inactivated, thus allowingradiation induced cross-linking.

It is a great advantage of the present invention that cross-linking isnot inhibited by having a high concentration of antioxidant. In fact,high concentrations of antioxidant can be advantageous in significantlyreducing the amount of oxidation of the polymer. Furthermore, theapplicants have found that the same cross-link density can be obtainedusing two very different amounts of antioxidant and so it has beendetermined that a high concentration of antioxidant on the polymerparticle surfaces does not inhibit cross-linking.

A possible disadvantage of the above method whereby antioxidant isblended with the polymer particles followed by cross-linkingirradiation, is that the antioxidant is subjected to high doses ofradiation. There is currently concern that irradiation of antioxidantmay produce harmful by-products. The applicant has surprisingly found,however, that the antioxidant blending of polymer particles can beperformed after irradiation and before moulding with heat and pressureinto the consolidated product. By this method, oxidation is stillprevented, but the antioxidant is not subjected to high doses ofcross-linking irradiation. In order to totally (or substantially)eliminate the occurrence of irradiation of antioxidant blended with theconsolidated polymer product, radiation sterilization should besubstituted with either gas plasma or ethylene oxide sterilization.

The applicant also believes that the antioxidant may not be needed afterthe consolidation step, since the heat that may be required forconsolidation may eliminate all free radicals. However, if a low dose ofirradiation was to be used on the consolidation (e.g. to sterilise thefinal component), free radicals would be formed during this process andthe antioxidant would neutralise these free radicals and preventoxidation in use. Further, high contact stress in use can causebreakdown of some cross-links and exposure of free radicals. Theantioxidant in the final product can therefore act as a safeguardpreventing oxidation in this eventuality by neutralising any freeradicals formed.

In certain embodiments of the present invention, the antioxidant (e.g.vitamin E) may constitute up to 3% of the weight of the mixture. Inparticular embodiments, the antioxidant (e.g. vitamin E) may constitute0.1%, 0.5%, 1%, 2%, or 3% of the weight of the mixture.

The step of forming the irradiated mixture into a consolidated componentmay comprise the use of heat and/or pressure (e.g. by performing hot orcold compression moulding). Where heat is employed in the consolidationprocess, it will be understood that any free radicals present in theirradiated mixture will be eliminated or minimised, thus obviating theneed for re-melting or annealing and thereby maintaining good mechanicalproperties of the consolidated material. Furthermore, as theconsolidated component contains antioxidant, any free radicals generatedduring future use of the component will tend to be neutralised by theantioxidant.

The polymer particles may be provided in the form of a resin (e.g.comprising powder, flakes and/or small pellets) or a hydrogel (e.g.comprising a polymer capable of absorbing water).

The antioxidant may be provided in the form of a liquid, powder,solution or suspension. For example, a powder (or liquid) antioxidantmay be dissolved in a solvent such as alcohol to increase the volume ofthe antioxidant containing element and allow it to more easily coat thepolymer particles. The solvent may be evaporated off after the blending.Alternatively, for example for insoluble antioxidants, the bulk of theantioxidant containing element can be increased by placing theantioxidant in a suspension of liquid (e.g. water).

The polymer particles may comprise a plurality of molecules.

The polymer particles may comprise the following but are not limitedthereto: polyethylene, polypropylene, polyamide, polyimide, polyetherketone, or any polyolefin, including high-density-polyethylene,low-density-polyethylene, linear-low-density-polyethylene, ultra-highmolecular weight polyethylene (UHMWPE), copolymers and mixtures thereof;hydrogels such as poly(vinyl alcohol), poly(ethylene glycol),poly(ethylene oxide), poly(acrylic acid), poly(methacrylic acid),poly(acrylamide), copolymers and mixtures thereof; copolymers andmixtures of a hydrogels with any polyolefin.

The antioxidant may comprise the following but is not limited thereto:vitamin E; alpha-tocopherol, delta-tocopherol; propyl, octyl, or dedocylgallates; lactic, citric, ascorbic, tartaric acids; organic acids andtheir salts; orthophosphates; tocopherol acetate and Irganox 1010.

The method may further comprise the step of processing the consolidatedcomponent, for example, using high pressure and/or high temperaturecrystallization. This may have the advantage of further improving themechanical properties of the consolidated component.

The consolidated component may form a product, a part of a product, orbar stock from which a product or a part of a product may be made (e.g.machined). The product may be constituted by a bearing component, amedical device, or a prosthesis. The prosthesis may be configured foruse in any joint, for example, the hip, knee, spine, neck, ankle, toe,shoulder, elbow, wrist, finger or thumb.

Where the consolidated component forms a part of a product, the part mayform a surface of the product, in particular, a surface that is normallyexpected to be subjected to wear (e.g. a bearing surface). The part mayconstitute the whole or a part of at least one surface of a product,such as an articular surface of a prosthesis.

Thus, a component formed by the present method may be used in partialarticular surface cross-linking (as will be disclosed in detail in thisapplication), full articular surface cross-linking, both the front andback elements of modular polymer bearing inserts to reduce front andback wear, both front and back elements of inserts for dual mobility hipbearings to reduce wear on both sides, and full component cross-linkingby forming the component using direct compression moulding (exploitingthe good mechanical properties of the material).

In embodiments of the invention, the component may be direct compressionmoulded into a porous or non-porous shell or backing material. The shellor backing material may be suitable for contacting bone (e.g. may beformed from metal, ceramic or polymer). The shell or backing materialmay be formed by, for example, casting, forging or machining from barstock (e.g. for a metal shell), or injection moulding or compressionmoulding (e.g. for a polymer shell).

The present method may used to form bulk material (i.e. wherein theconsolidated component of the first aspect of the invention is in theform of bulk material, e.g. in the form of large compression mouldedsheets or long ram extruded rods). The step of forming the bulk materialmay therefore be by compression moulding, ram extrusion or other knownmethods. Products such as implants (or parts therefor) may then bemachined from the bulk material.

In certain embodiments of the invention, irradiation of the polymerpowder (with or without blended antioxidant) is carried out in thepresence of a sensitizing gas or liquid (e.g. acetylene).

The method according to the first aspect of the invention may beconfigured for forming an articular surface (or a part of an articularsurface) for an acetabular cup prosthesis. In which case, the articularsurface may be configured as a liner for an acetabular cup configuredfor use in either total hip replacement or hip resurfacing. In specificembodiments, the articular surface may be configured for use in anacetabular cup comprising any of the features described below inrelation to the fifth to fifteenth aspects of the present invention.

According to a second aspect of the present invention there is provideda method of forming an articular surface for a prosthesis comprising:

-   -   forming a first layer comprising a first polymer;    -   forming a second layer comprising a second polymer, wherein the        second layer constitutes the whole or a part of an articular        surface layer;    -   joining the first and second layers together to form an        articular surface component;    -   irradiating the second polymer to cross-link the molecules        therein; and facilitating the consumption of free radicals in        the second layer to thereby minimise the risk of oxidation of        the second layer.

The first and second polymers may be the same or different prior to thestep of irradiation.

The first layer may further comprise an antioxidant. The antioxidant maycomprise the following but is not limited thereto: vitamin E;alpha-tocopherol, delta-tocopherol; propyl, octyl, or dedocyl gallates;lactic, citric, ascorbic, tartaric acids; organic acids and their salts;orthophosphates; tocopherol acetate and Irganox 1010. The first layermay include at least 1% by weight of vitamin E. In a first embodiment,the first layer may include 2% by weight of vitamin E. In a secondembodiment, the first layer may include 3% by weight of vitamin E. Itwill be noted that the amount of antioxidant provided in the first layermay be selected so as to prevent cross-linking of the first layer whenthe second polymer is irradiated.

It will be understood that since the second layer is intended to becross-linked, it may be desirable that no antioxidant is present in thislayer. However, in practice, a small amount of antioxidant maynevertheless be present in this layer as long as it is not sufficient tosignificantly prevent the formation of cross-linked bonds in the secondlayer. Thus, a low concentration of antioxidant (e.g. vitamin E) of,say, less than 0.2%, may be present in the second layer. For example,the second layer may contain 0.05% or 0.1% of antioxidant (e.g. vitaminE).

The step of facilitating the consumption of free radicals in the secondlayer may be performed by ensuring that the concentration of antioxidantin the second layer is low enough to allow polymer cross-linking withradiation but high enough to consume the free radicals generated as aresult of the radiation.

It will be understood that the step of joining the first and secondlayers together may comprise the application of heat and/or pressure.Thus, the first and second layers may be joined by hot compressionmoulding. Alternatively, they may be cold compression moulded or joinedby an adhesive or mechanical means.

The second polymer may be irradiated before or after it is formed intothe second layer. Thus, the second layer may be formed in accordancewith the first aspect of the present invention (i.e. by coating thesecond polymer with antioxidant, before or after the polymer isirradiated, and then forming the irradiated mixture into the secondlayer). Additionally or alternatively, the second polymer may beirradiated after the second layer has been joined to the first layer.

It may be advantageous to irradiate the second polymer prior to thesecond layer being joined to the first layer, since this may negate theneed to alter the first polymer (e.g. by mixing it with an antioxidant)so as to prevent the first polymer from cross-linking, thereby weakeningthe first layer. Alternatively, irradiating the second polymer prior tothe second layer being joined to the first layer could mean that afterthe first and second layers are joined only a low dose of radiation isrequired to obtain the desired amount of cross-linking in the secondlayer—thus, again, minimizing damage to the first layer as a result ofthe radiation.

The second polymer may be irradiated with approximately 100 kGy ofabsorbed radiation.

The step of facilitating the consumption of free radicals may compriseheating to encourage the antioxidant when present in the first layer todiffuse into the second layer to consume the free radicals therein. Thisstep can be considered an annealing step wherein the component is heatedto below its melting point.

The steps of forming the first and/or second layers may comprisemoulding. The moulding may comprise compression moulding and may be inthe form of either cold compression moulding or hot compressionmoulding. The first layer may be moulded from a first powder comprisingthe first polymer and, optionally, the antioxidant. The second layer maybe moulded from a second powder comprising the second polymer. The firstand/or second powders may comprise a mix of particle sizes (e.g. fromfine particles to flakes).

Alternatively, the steps of forming the first and/or second layers maycomprise machining. The first layer may be machined from a first barstock comprising the first polymer and the antioxidant. The second layermay be machined from a second bar stock comprising the second polymer.The first and/or second bar stock may be formed by compression mouldinga block (e.g. having dimensions of 3 m by 2 m by 10 cm) of the relevantmaterials. For example, the first bar stock may be formed by compressionmoulding a first block from a first powder comprising the first polymerand, optionally, the antioxidant and/or the second bar stock may beformed by compression moulding a second block from a second powdercomprising the second polymer. Alternatively, the first and/or secondbar stock may be formed by ram extrusion.

In a certain embodiment, the step of forming the first layer maycomprise compression moulding the first layer by placing the firstpowder into a mould and hot or cold compression stamping (e.g. with 10tonnes of pressure) the first powder into the desired shape of the firstlayer. When present, the antioxidant may be mixed or blended into thefirst polymer powder. The desired shape may include multiple protrusionsin the intended wear zone to diffuse the interface between the first andsecond layers.

In a particular embodiment, the step of forming the second layer maycomprise compression moulding by placing the second polymer powder overthe whole or part of the formed first layer and applying a second mouldto hot or cold compression stamp the desired shape of the second layer.In certain embodiments, this step may therefore comprise filling thearea surrounding the protrusions created in the first layer with thesecond powder before applying the second mould to compression stamp thedesired shape of the second layer.

In a specific embodiment, the first polymer powder may be compressionmoulded by applying a first piston through a syringe-like shroud. Thefirst piston may then be removed from the shroud and the second polymerpowder passed down the shroud before a second piston is applied throughthe shroud to compression mould the second layer onto the first layer.It has been found that this technique is particularly advantageous whenthe second layer forms only a part of an articular surface layer sincethe shroud helps to ensure that the second powder is not accidentallydeposited on the first layer in the region outside that which isintended.

Alternatively, the step of forming the second layer may comprisecompression moulding by placing the second powder into a second mouldand hot or cold compression stamping the second powder into the desiredshape of the second layer. This technique is expected to be particularlyadvantageous when the second layer forms the whole or a part of anarticular surface layer which is not flat since it is difficult toevenly deposit the second powder onto a non-flat surface so as to obtaina second layer having an even (or pre-determined) thickness. Thus, inthe case where the second layer forms a whole or a part of an articularsurface layer of an acetabular cup prosthesis, it may be desirable toform the second layer separately from the first layer so as to ensurethat the second powder does not accumulate in the pole of the cupthereby producing a thicker than intended layer of cross-linked polymerat the pole of the cup and a thinner than intended layer of cross-linkedpolymer at the periphery of the cup.

In a variant of the above method, the second powder may include apre-determined amount of antioxidant, the concentration of which isdetermined to be low enough so as not to prevent cross-linking of thesecond layer but high enough so as to neutralise the oxidising effect offree radicals produced during the cross-linking process. In a furthervariant of the above, the second powder may include a relatively highconcentration of blended antioxidant (e.g. 2% vitamin E), wherein thesecond powder is irradiated to cause extensive cross-linking of thesecond powder particles prior to formation of the second powder into thesecond layer.

In yet another variant of the second aspect of the present invention,the method may comprise cross-linking at least one further portion ofthe articular surface layer and/or at least one further surface of thecomponent. This may be achieved using any of the methods describedherein. In particular embodiments, the method could be employed tocross-link part of the articular surface and the whole (or part) of aback surface of a modular polymer acetabular bearing insert/liner toprevent or minimise wear of the back surface of the polymer against ametal acetabular cup shell. Other modular bearing inserts would alsobenefit by having their back surfaces highly cross-linked (for example,the back surface of a modular polymer bearing for a knee tibialcomponent). In other embodiments, two (or more) surfaces may serve asarticular bearing surfaces (e.g. in dual mobility hip bearings) and sothese would also benefit from cross-linking in more than one area.

The method according to the second aspect of the invention may beconfigured for forming an articular surface for an acetabular cupprosthesis. In which case, the articular surface may be configured as aliner for an acetabular cup configured for use in either total hipreplacement or hip resurfacing. In specific embodiments, the articularsurface may be configured for use in an acetabular cup comprising any ofthe features described below in relation to the fifth to fifteenthaspects of the present invention.

An alternative method to that described above is specified below as athird aspect of the present invention. This method of forming anarticular surface for a prosthesis comprises:

-   -   forming a polymer component comprising an antioxidant;    -   selectively removing the antioxidant, wholly or in part, from a        portion of an articular surface layer;    -   irradiating the component to cross-link the molecules in said        portion; and    -   facilitating the consumption of free radicals in said portion to        thereby minimise the risk of oxidation of said portion.

The step of removing the antioxidant from a portion of an articularsurface layer may comprise leaching out the antioxidant using asurfactant.

In embodiments of the third aspect of the invention, the method mayfurther comprise selectively removing the antioxidant, wholly or inpart, from at least one further portion of the articular surface layerand/or from at least one further surface of the component. The componentmay then be irradiated to cross-link the molecules in more than oneportion and/or more than surface. In particular embodiments, the methodcould be employed to cross-link part of the articular surface and thewhole (or part) of a back surface of a modular polymer acetabularbearing insert/liner to prevent or minimise wear of the back surface ofthe polymer against a metal acetabular cup shell. Other modular bearinginserts would also benefit by having their back surfaces highlycross-linked (for example, the back surface of a modular polymer bearingfor a knee tibial component). In other embodiments, two (or more)surfaces may serve as articular bearing surfaces (e.g. in dual mobilityhip bearings) and so these would also benefit from cross-linking in morethan one area.

In a fourth aspect of the present invention, a method of forming anarticular surface for a prosthesis comprises:

-   -   forming a polymer component comprising an antioxidant;    -   selectively inactivating the antioxidant, wholly or in part,        from the whole or a portion of an articular surface layer;    -   irradiating the component to cross-link the molecules in said        articular surface layer; and    -   facilitating the consumption of free radicals in said articular        surface layer to thereby minimise the risk of oxidation of said        articular surface layer.

The step of inactivating the antioxidant may comprise exposing theantioxidant to sunlight.

In embodiments of the fourth aspect of the present invention, the methodmay comprise cross-linking at least one further portion of the articularsurface layer and/or at least one further surface of the component. Thismay be achieved using any of the methods described herein. In particularembodiments, the method could be employed to cross-link the whole (or apart) of the articular surface and the whole (or a part) of a backsurface of a modular polymer acetabular bearing insert/liner to preventor minimise wear of the back surface of the polymer against a metalacetabular cup shell. Other modular bearing inserts would also benefitby having their back surfaces highly cross-linked (for example, the backsurface of a modular polymer bearing for a knee tibial component). Inother embodiments, two (or more) surfaces may serve as articular bearingsurfaces (e.g. in dual mobility hip bearings) and so these would alsobenefit from cross-linking in more than one area.

The following features are optional features of both the third andfourth aspects of the invention as defined above.

The antioxidant may comprise the following but is not limited thereto:vitamin E; alpha-tocopherol, delta-tocopherol; propyl, octyl, or dedocylgallates; lactic, citric, ascorbic, tartaric acids; organic acids andtheir salts; orthophosphates; tocopherol acetate and Irganox 1010.

The step of forming the polymer component may comprise moulding (e.g.hot or cold compression moulding) and/or machining.

The step of facilitating the consumption of free radicals may beperformed by ensuring that the concentration of antioxidant in theportion/articular surface layer is low enough to allow polymercross-linking with radiation but high enough to consume the freeradicals generated as a result of the radiation. Alternatively, the stepof facilitating the consumption of free radicals may be performed byheating the component to encourage the antioxidant to diffuse from theremainder of the polymer component into the portion/articular surfacelayer to consume free radicals therein and thereby minimise the risk ofoxidation.

The method according to the third or fourth aspects of the invention maybe configured for forming an articular surface for an acetabular cupprosthesis. In which case, the articular surface may be configured as aliner for an acetabular cup configured for use in either total hipreplacement or hip resurfacing. In specific embodiments, the articularsurface may be configured for use in an acetabular cup comprising any ofthe features described below in relation to the fifth to fifteenthaspects of the present invention.

The present invention also relates to products and components producedby any of the methods described above in relation to the first to fourthaspects of the invention.

According to a fifth aspect of the present invention there is provided aprosthesis having a polymer articular bearing surface wherein at leastone pre-determined portion of said bearing surface is provided withcross-linked polymer bonds.

In embodiments of this aspect of the invention, the pre-determinedportion will be arranged to correspond to the region that is believed toencounter the greatest abrasion from a mating articular surface (i.e.the pre-determined portion will be chosen to correspond to the zonelikely to be subjected to the greatest amount of wear). It will beunderstood that a skilled person will readily be able to determine thelikely wear zone from the geometry of the bearing surface and the matingarticular surface, in view of the anticipated skeletal forces exhibitedby the patient.

It is noted that, in the case of traditional acetabular cups havinguntreated (i.e. conventional) polyethylene inner liners, the volume ofwear debris is found to be proportional to the size of the femoral heademployed. Thus, in the case of total hip replacement, where, forexample, 22 mm diameter heads are commonly used, the volume of weardebris from the polyethylene liner may be of an acceptable level.However, in the case of hip resurfacing it is common to use 45 to 55 mmdiameter heads and, as a result, the volume of wear debris is relativelymassive leading to unacceptable levels of wear, resulting in damage tothe remaining bone stock. There is therefore a need for a high strengthpolymer which exhibits very low wear even when provided in thin layersagainst large femoral heads.

As described above, it is possible to prevent a polymer (e.g.polyethylene) from exhibiting any measurable wear by cross-linking itspolymer bonds. This may be achieved by irradiating moulded orram-extruded polymer. Whilst this does result in hard-wearingcross-linked polymer bonds, the process leaves free radicals whichcombine with oxygen such that the oxidised polymer is mechanically weakand therefore prone to breaking. It is possible to eradicate the freeradicals (to prevent oxidation) by re-melting the material afterradiation. This is known to give some reduction in the mechanicalproperties of the material (i.e. to make it weaker than before) butwithout weakening it as much as the oxidation process would. Thisprocess results in so-called first generation cross-linked polymer.

Second generation cross-linked polymer can be obtained by diffusingvitamin E into the substance of the polymer. The vitamin E is diffusedafter irradiation cross-linking such that the free radicals produced asa result of the cross-linking are consumed by the vitamin E. Morespecifically, the cross-linked polyethylene is immersed in a warm bathof liquid vitamin E and over several hours the vitamin E diffuses intothe material. It is noted that second generation cross-linking cannot beperformed by having substantial concentrations of vitamin E in thepolyethylene powder before moulding or ram extrusion, as vitamin E andother anti-oxidants are known to prevent cross-linking.

Third generation cross-linking relates to cross-linking only the surfaceof a material. It has been found that increasing the concentration ofvitamin E in the substance (prior to irradiation), decreases the amountof cross-linking and so vitamin E can effectively be used to preventcross-linking in the bulk of the polymer—allowing only the surface layerto be cross-linked. It is then desirable to allow the vitamin E todiffuse into the surface layer so as to consume the free radicalsresulting from the cross-linking process to prevent oxidation. In thiscase, the vitamin E from the bulk material is persuaded to diffuse intothe surface cross-linked layer by annealing the material below itsmelting temperature for several hours.

The present aspect of the invention relates to partial surfacecross-linking, which could be considered forth generation cross-linking.In essence only a selected part (or parts) of the surface iscross-linked to ensure that the intended wear zone is highly resistantto wearing while preserving the mechanical strength of the remainder ofthe polymer material. The fact that the cross-linking is limited to onlya portion of the surface of the material is particularly advantageouswhere only thin layers of polymer are used since, in this case, themechanical strength of the entire polymer construct is determinedlargely by the mechanical strength of the bulk material and the surfaceof the material surrounding the cross-linked area, which retains thestrength of a conventional polymer.

It is believed that first, second and third generation cross-linkedpolymers lack the strength required for use in thin layer hipresurfacing components. However, it is believed that fourth generation(i.e. partial surface) cross-linking will provide sufficient strength(akin to that of conventional, non-cross-linked polymer) plus sufficientwear resistance in the area of articulation, even when used in thinlayers as required in hip resurfacing, particularly when large femoralheads are employed.

It is also noted that metal-on-metal, ceramic-on-ceramic, andmetal-on-cross-linked polymer bearings are all intolerant of so-callededge loading. Edge loading occurs when component mal-alignment (commonlycup misplacement due to surgeon error) results in load being transmittedfrom a prosthetic femoral head onto the edge of a prosthetic acetabularcomponent. With metal-on-metal bearings this results in severe wear ofthe component parts. With ceramic-on-ceramic bearings this results infracture of the prosthetic acetabular cup edge, due to ceramic being abrittle material. With a metal head on a fully cross-linked polyethyleneacetabular cup liner, fracture of the cup liner can occur due to therelatively poor strength of the cross-linked material. It is noted thatconventional polymer (e.g. polyethylene) bearings perform better inrelation to edge loading than cross-linked polymer bearings sinceconventional polymer is stronger and tends not to fracture underconditions of edge loading, making the implant more forgiving of minormal-position by the surgeon. Since the prosthesis of the present aspectof the invention is configured with only a small portion which iscross-linked and importantly leaving the edge of the component asconventional non-cross-linked polymer, it is believed that themechanical properties of the prosthesis will be much more like those ofconventional polymers and so it is expected that edge loading will notbe a significant problem.

In certain embodiments, the polymer may be made thicker in the region ofthe pre-determined portion. This will help to ensure that the mechanicalproperties of the hulk of the material are unaffected by the surfacecross-linking of the pre-determined portion.

The Applicant notes that there is a difference in the degree ofcrystallinity in the cross-linked polymer (e.g. polyethylene) portionthan in the non-cross-linked polymer. Consequently, there is a concernthat an abrupt interface between the two types of polymer will result ina high risk of de-lamination at the interface. The Applicant thereforeproposes that multiple protrusions may be provided at the interfacebetween the cross-linked polymer portion and the remainder of thepolymer so as to obviate or minimise the risk of de-lamination at thisinterface. The protrusions may be in the form of ridges or fingers, forexample in the shape of spikes, or they may be provided by introducingroughness at the interface between the two types of polymer. It will beunderstood that the interdigitation of the material resulting from theprovision of the protrusions will help to break up the sharp transitionbetween the two types of polymer so as to provide a smoother transitionbetween the two mechanically different varieties of the polymer (e.g.polyethylene).

The prosthesis may be configured as an acetabular cup. The acetabularcup may comprise a metal outer shell and a polymer inner liner, theinner surface of which constitutes the articular bearing surface havingsaid pre-determined portion provided with cross-linked polymer bonds.

It will be understood that the various features described above inrelation to the first to fourth aspects of the present invention may becombined with any of the features described above in relation to thefifth aspect of the invention, and vice versa.

The prosthesis may be configured as a femoral component or a tibialcomponent for use in total knee replacement techniques. In particular,the articular bearing surface may be constituted by the condylar bearingsurfaces provided on the tibial component. Additionally oralternatively, the articular bearing surface may be constituted by oneor both mating surfaces of a cam and peg follower, one of which isprovided on the femoral component and the other of which is provided onthe tibial component.

According to a sixth aspect of the present invention there is providedan acetabular cup prosthesis comprising a metal outer shell and apolymer inner liner, wherein a mechanical means is provided to attachthe inner liner to the outer shell to form a composite one-piece cup.

The sixth aspect of the present invention helps to overcome some of thedisadvantages of metal cups described above (such as extreme patientallergies to metal, and wear of metal leading to excess metal ions in apatient's blood with possible long-term effects) by employing a polymerlayer between the metal shell and the femoral component. An advantage ofmechanically attaching the polymer layer to the metal shell is that thecup can be handled and inserted as a one-piece device which is strongerand more robust than its individual component parts. The likelihood ofdeformation of the cup on insertion is therefore reduced.

It will be understood that the metal shell of the present aspect of theinvention is constituted by a solid piece of metal initially formed as adiscrete component.

In an embodiment, the metal outer shell may be relatively thin and thepolymer inner liner may be relatively thick. This helps to reduce therisk of metal debris whilst at the same time helping to ensure that thestresses generated in the polymer (from the forces exerted by thefemoral head) are more easily absorbed in the thicker polymer layer.

The metal shell may have a thickness of approximately 0.5 mm to 6 mm. Incertain embodiments the metal shell may have a minimum thickness ofapproximately 1 mm. The thickness of the metal shell may vary, forexample, from its edges to its pole.

The polymer liner may have a thickness of approximately 0.5 mm to 10 mm.In certain embodiments the polymer liner may have a minimum thickness ofapproximately 4 mm in a pre-determined wear zone and 1 mm in otherregions. Thus, the thickness of the polymer liner may vary, for example,from its edges to its pole.

The mechanical means may comprise at least one bore, aperture, slot,recess or undercut in the metal shell into which the polymer linerextends so as to mate the inner and outer shells together.

In one embodiment, the mechanical means is constituted by, or comprises,a plurality of undercut spheres provided in the inner surface of themetal shell. In this case, the polymer liner may be compression mouldedonto the metal shell so as to form a plurality of polymer nodules whichare retained by the metal undercuts. This embodiment is particularlyeffective at securing the inner and outer shells together. The pluralityof undercut spheres (and respective polymer nodules) may be providedover a substantial portion of the metal shell and may be provided closeto the edge of the metal shell, even when the metal is relatively thinin that area.

Furthermore, the size of each of the undercut spheres may vary dependingon the thickness of the metal in a particular location.

In some embodiments, the mechanical means may comprise stitching of theinner liner to the outer shell. The stitching may be provided along thewhole or part of the cup edge. In particular embodiments, the outershell may be provided with a rim around the whole or part of the cupedge. The rim may be perforated with a plurality of holes through whichthe polymer inner liner may extend to stitch the liner and shelltogether. The rim may be inset from the external surface of the outershell to allow for a portion of the polymer inner liner to extend alongor envelope the exterior surface of the rim, within the cup profile. Inembodiments where the polymer liner is moulded (e.g. direct compressionmoulded (DCM)) into the outer shell, threads of the polymer will beforced through the holes in the rim and then moulded into the polymerprovided around the rim to thereby stitch the edge of the liner to theshell. An advantage of using this technique is that it is easier tomanufacture than the undercuts described above. The stitching may alsobe advantageous in connection with other aspects of the inventiondescribed below since it can help to retain the liner within the shelleven when forces are applied which might otherwise serve to detach theliner from the shell.

In addition to the above, the mechanical means may comprise a(relatively large) threaded hole provided at the interior pole of themetal shell. The hole may be a blind hole and can be used in thehandling of the metal shell during manufacture. In embodiments where thepolymer liner is moulded (e.g. direct compression moulded (DCM)) intothe outer shell, the threaded hole may provide macro-fixation. Inaddition, if the cup ever has to be removed from the patient, thepolymer in the hole can be drilled out and the shell grasped byinserting a threaded rod into the threaded hole.

Alternatively, or additionally, the mechanical means may comprise arough interior surface provided on the whole or a portion of the outershell for micro-attachment of the polymer liner.

It is noted that although glue is unlikely to prevent de-lamination ofthe inner liner and outer shell on its own it could advantageously beused in combination with any of the above mechanical means.

The polymer liner may comprise one or more of polyimide, polyurethane,hylamer, carbon-fibre reinforced “PEEK” (Polyetheretherketone) orUltra-High Molecular Weight Polyethylene (UHM WPE).

The metal shell may comprise one or more of titanium, titanium alloy orcobalt chrome.

It will be understood that, when the inner liner and outer shell areboth relatively thin, it is advisable not to rely on a press-fitfixation within the body because of the risk of deformation. It istherefore important to consider an alternative form of fixation and asuitable means for handling and inserting the cup during surgery. Theseaspects of the invention will therefore be discussed in more detailbelow.

It will be understood that the various features described above inrelation to the fifth aspect of the present invention may be combinedwith any of the features described above in relation to the sixth aspectof the invention, and vice versa.

According to a seventh aspect of the present invention there is providedan acetabular cup prosthesis comprising an outer surface and an innersurface, wherein the centre of the inner surface is displaced withrespect to the outer surface so as to allow for an increased cupthickness in a pre-determined wear zone and wherein a cut-out isprovided at an inferior edge of the cup to compensate for thedisplacement of the inner surface.

With current hip resurfacing techniques it is generally felt necessaryto have a cup with an inner diameter to outer diameter difference of 6mm so as to accommodate a reasonably sized femoral head in a robustacetabular cup prosthesis. However, it has been found that pseudotumoursare more common in patients (particularly women) of small size. TheApplicants therefore propose the present invention to allow for anincreased femoral head size (i.e. through provision of a displaced innersurface) whilst maintaining the outer cup diameter. This will ensure thejoint is more stable and has a larger surface area of contact therebyspreading the loads applied more effectively to reduce wear, whileensuring that no additional bone is resected from the acetabular cavity.

It will be understood that by displacing the inner surface with respectto the outer surface, a smaller inner diameter to outer diameterdifference can be obtained. The provision of the inferior cut-out alsohelps to maximize the size of the inner diameter since no thickness ofcup is required at the inferior edge.

The cup may be constituted by a single component (i.e. a mono-block), orby two or more components (e.g. having an outer shell and an innerliner—the outer surface being provided by the outer shell and the innersurface being provided by the inner liner).

The component (or components) may be formed from metal, ceramic,polymer, or a composite thereof.

Thus, the cup may comprise a single metal, ceramic, polymer or compositecomponent.

Alternatively, the cup may comprise a metal, ceramic, polymer orcomposite shell and at least one metal, ceramic, polymer or compositeliner. Any combination of shell material and liner material is possible.Thus, the shell and liner may comprise the same or different materials.

The outer surface (e.g. of the single component or the shell) maycomprise a porous coating. The porous coating may be constituted by a(vacuum or non-vacuum) plasma sprayed metal (e.g. titanium) coating.Prior to application of the porous coating, the outer surface may besculptured to create a series of protrusions (e.g. spikes) and/orindentations (e.g. pits). This may be achieved using known laser ore-beam sculpturing techniques, by casting (e.g. of a spiky surface), byforging the surface, or by machining the surface. In other embodiments,the porous coating may be formed by sintering or it may be formedseparately and then attached to the outer surface of the cup (e.g.factory fitted by gluing or welding). In further embodiments, the porouscoating may be integrally formed with the outer surface of the cup (e.g.by using a lost-wax technique to cast a shell having an integral latticeon its outer surface).

The centre of the inner surface (i.e. the centre of articulation) may bedisplaced outwardly of the outer surface and/or inferiorly thereof.

The inner surface may be displaced outwardly by 3.5 mm to increase thethickness in the pre-determined (i.e. intended) wear zone.

In other embodiments, the inner surface may be displaced outwardly by 7mm and inferiorly by 2 mm. In a cup having a 56 mm outer diameter, thisdisplacement will provide a 54 min inner diameter, permitting use of a54 mm diameter femoral head instead of a standard 50 mm diameter head(as would normally be used in a 56 mm outer diameter cup, sincetraditionally the inner diameter of such a cup would only accommodate a50 mm diameter head).

It will be understood that the pre-determined wear zone may be locatedapproximately in the centre of the cup but will more usually be locatedaround the polar region of the inner surface and/or the superior regionof the cup.

The cup may include one or more strengthening ribs on its outer surface.The strengthening ribs may be disposed in the region adjacent theperiphery of the cup. The strengthening ribs may extend in alongitudinal direction towards the pole of the outer surface. Thestrengthening ribs may terminate short of the pole, for example, whenthe thickness of the cup reaches a pre-defined value.

In embodiments where the outer surface includes a porous coating, thestrengthening ribs may be provided to butt against a moulding tool, thuspreventing crushing of the porous coating between the ribs.

It will be understood that various features described in relation to thefifth, sixth and eighth to fifteenth aspects of the present inventionmay be combined with any of the features described above in relation tothe seventh aspect of the invention, and vice versa.

According to an eighth aspect of the present invention there is providedan acetabular cup prosthesis comprising a metal outer shell and apolymer inner liner, wherein the centre of the polymer inner liner isdisplaced with respect to the metal outer shell so as to allow for anincreased cup thickness in a pre-determined wear zone and wherein acut-out is provided at an inferior edge of the cup to compensate for thedisplacement of the inner liner.

In conventional hip replacement there is no constraint on the thicknessof the acetabular component. The acetabular component is press-fittedinto place and since the femoral head and part of the femoral neck areresected, a prosthetic femoral head is used with a diameter much lessthan the diameter of the natural femoral head. Typically, this willresult in a difference of approximately 18 mm between the outer andinner diameters of such an acetabular component (e.g. the cup may have athickness of approximately 9 mm around its periphery). However, the aimof hip resurfacing is to preserve as much bone as possible by onlyreplacing the surface layer. It is therefore desirable to have a muchsmaller outer diameter to inner diameter difference and the presentApplicant believes that a difference of approximately 6 mm may beoptimal in certain circumstances for preserving bone whilst at the sametime allowing for insertion of a robust resurfacing cup.

In order to provide an inner diameter to outer diameter difference ofapproximately 6 mm (e.g. to allow for a 56 mm outer diameter cup for usewith a 50 mm outer diameter head), it is possible to design a cup havinga 1 mm thick metal shell and a 2 mm thick polymer liner, thus resultingin a total cup thickness of 3 mm all over. However, the Applicant hasfound that having only 2 mm of polymer in the pre-determined wear zone(i.e. in the region that is believed to encounter the greatest pressurefrom the femoral head) is not ideal because the high internal stressesexperienced by the polymer in this region causes it to delaminate andwear away. The Applicant therefore proposes to displace (i.e. offset)the centre of the polymer liner so that the thickness of the cup can beincreased in this region, without requiring more bone to be removed.

The centre of the inner liner (i.e. the centre of articulation) may bedisplaced outwardly of the metal shell and/or inferiorly thereof.

If we consider the case of a hemispherical cup (i.e. without a cut-out)having a metal shell of uniform 1 mm thickness, it will be noted thatwhen the centre of the inner liner is displaced so as to provide 4 mm ormore of polymer at the superior aspect of the cup (in addition to the 1mm metal shell), it will not be possible to provide any polymer at theopposite, inferior edge of the cup (in addition to the 1 mm metalshell), if we wish to retain an inner to outer diameter difference of 6mm. Thus, the Applicant proposes to provide a cut-out at the inferioredge of the cup so as to negate this problem and allow for maximum cupthickness in the region of highest wear whilst ensuring that a minimumthickness of metal and polymer is provided over the entire surface ofthe cup. In addition, the cut-out helps the surgeon to orientate the cupfor correct placement (e.g. to ensure the cup is not inserted upsidedown).

In light of the above, the inner liner may be displaced such that a 1 mmthickness metal shell is provided with polymer liner having a 4 mmthickness in the pre-determined (i.e. intended) wear zone and a 1 mmthickness at the inferior edge.

It will be understood that the predetermined wear zone may be locatedapproximately in the centre of the cup but will more usually be locatedaround the polar region of the inner liner and/or the superior region ofthe cup.

In certain embodiments, the metal shell may be thicker in the regionadjacent the pre-determined wear zone than at its inferior edge. Forexample, the metal shell may include an inwardly extending bulge (e.g.in the form of a convex saucer) of 2 to 4 mm thickness in this region.Advantages of this construction are that the additional metal providesincreased strength and stiffness at the polar region and also that itallows for the attachment and/or support of fixation means on theexterior surface of the cup, as will be described in more detail below.A further advantage of having a thicker shell at the pole of the cup isthat the centre of rotation of the prosthetic articulation is displacedlaterally and into a closer to normal position than is commonly observedwith conventional hip resurfacing prosthetic cups.

It will be noted that, in embodiments where the thickness of the metalis increased in the region adjacent the pre-determined wear zone, thethickness of the polymer liner may or may not be reduced in the sameregion, since the desired outer to inner diameter difference can bemaintained in both cases by taking into account the lateral displacementof the articular surface.

The metal shell may be thin (e.g. 1 mm thick) around the entireperiphery of the cup.

The metal shell may include one or more strengthening ribs on itsexterior surface. The strengthening ribs may be disposed in the regionadjacent the periphery of the cup. The strengthening ribs may extend ina longitudinal direction towards the pole of the shell. Thestrengthening ribs may terminate short of the pole, for example, whenthe thickness of the metal and/or polymer liner reaches a pre-definedvalue.

In certain embodiments, the outer surface of the cup may include aporous coating and so the strengthening ribs may be provided to buttagainst a moulding tool, thus preventing crushing of the porous coatingbetween the ribs.

The metal shell may include a beveled edge. The beveled edge may beinclined inwardly. This feature can help to maximise the thickness ofthe polymer liner around the edge of the cup whilst maintaining thedesired inner diameter.

The polymer liner may include a rounded edge. The rounded edge mayextend over the edge of the metal shell to ensure no sharp metal edgesare exposed to the patient or surgeon and, in particular, that any sharpedges are prevented from scratching the femoral head in the event ofunwanted subluxation or dislocation.

Alternatively, the polymer liner may extend beyond the edge of the metalshell with an outer diameter equal to that of the metal shell so as toprovide a continuous extension thereto. The edge of the polymer linermay be sloped outwardly so as to maximise the articular surface area.

It will be understood that the various features described above inrelation to the eighth aspect of the present invention may be combinedwith any of the features described in relation to the fifth to seventhaspects of the invention, and vice versa.

According to a ninth aspect of the present invention there is providedan acetabular cup prosthesis comprising a metal outer shell and apolymer inner liner, wherein an attachment means is provided whichprojects from or through the polymer liner for attachment of the cup toan introducer configured for insertion of the cup into a patient.

An advantage of this aspect of the present invention is that attachmentmeans is readily available for handling and orientating the cup, withouthaving to (correctly) attach any additional components first. Inaddition, the fact that the attachment means projects from or throughthe polymer liner means that they cannot project from the curved outersurface of the metal shell. Accordingly, they do not interfere with theplacement of the cup in the prepared bone of the acetabulum. In otherwords, the acetabulum can be prepared as normal, simply taking intoaccount the size and shape of the outer shell of the cup. No additionalcut-outs are required in order to accommodate the attachment means.Furthermore, the polymer surrounding the attachment means can help tocushion the interface between the cup and the introducer when attached.

The attachment means may project from or through the edge of the polymerliner. The attachment means may project from or through the edge in adirection generally perpendicular to the plane of the edge. In certainembodiments, the attachment means may be sloped or curved inwardlytowards the centre of the cup. For example, the attachment means mayproject from or through the edge at an angle of, say, 5, 10, or 20degrees inwardly from the perpendicular direction. Alternatively, theattachment means may extend from or through the curved inner surface ofthe polymer liner.

The attachment means may be formed as an integral part of the polymerliner (e.g. by injection or compression moulding).

Alternatively, the attachment means may be formed as an integral part ofthe metal shell. In this case, the polymer liner may be moulded aroundthe attachment means so that it protrudes therefrom.

In certain embodiments, the attachment means may be joined to the metalor polymer liner by melting or gluing or by mechanical means such as bysmall loops.

The attachment means may comprise one or more loops having a first endand a second end secured to the cup. The loops may be thickest at theirfirst and second ends so as to provide more support at these joints. Inone embodiment, two loops are provided, one on each side of the cup. Theloops may be integrally moulded with the polymer liner. After insertionof the cup into a patient, the loops may be removed (e.g. by cutting thefirst and second ends from the polymer liner) so as to leave the polymerliner with a relatively flush, smooth surface.

The attachment means may comprise one or more projections having aserrated surface. Alternatively, the attachment means may comprise oneor more projections having a device configured to lock onto a serratedsurface. The device may include an opening having a ridge arranged tolocate between two adjacent serrations. The device may be configured toeasily accept the serrated surface (i.e. to allow the serrated surfaceto be inserted into it) but to prevent the serrated surface from beingremoved from its grasp.

In other words, the device may be configured to allow the serratedsurface to be passed through it in one direction but to prevent theserrated surface from passing through it in the opposite direction.Thus, the attachment means in these embodiments may take the form ofcable ties, with either the serrated surface or the device for lockingonto the serrated surface being provided as the attachment means on thecup and the other of the serrated surface or the device for locking ontothe serrated surface being provided on the introducer.

In a further embodiment the attachment means may comprise one or moreprojections. The projections may be in the form of fingers or straps.The projections may have a smooth exterior surface. In this case, theintroducer may comprise gripping means for gripping onto theprojections. The gripping means may comprise teeth arranged to bite intothe projections.

The attachment means may comprise one or more rods. The rods may beprovided with an enlarged portion at their free ends configured forgripping by an introducer. The enlarged portion may be spherical. In acertain embodiment the enlarged portion may be generally conical andorientated with its tip at the free end of the rod. In one embodimentthe enlarged portion may comprise two or more conical portions stackedwith their tips all towards the free end of the rod. The rods mayinclude a neck configured such that rotation of the rod with respect tothe inner and outer shells will cause the rod to shear at the neck. Inone embodiment the rods may be extensions of the polymer liner and, inthis case, the location of the neck may be close to the base of eachrod. In another embodiment the rods may be extensions of the metal shelland, in this case, the location of the neck may be below the height ofthe polymer liner through which it extends. This embodiment isparticularly advantageous, because the polymer liner can serve toprotect the surrounding tissue from damage by the portions of the metalrods remaining after the cup has been inserted.

It will be understood that the various features described above inrelation to the fifth to eighth aspects of the present invention may becombined with any of the features described above in relation to theninth aspect of the invention, and vice versa.

According to a tenth aspect of the present invention there is providedan impactor cap for an acetabular cup prosthesis comprising a bulbousouter surface configured to fill the interior of said acetabular cup;and a flange configured to extend around the outer edge of the cup andto rest thereon when said bulbous surface fills the cup interior.

This aspect of the invention therefore provides a device which snuglyand completely mates with an acetabular cup and therefore it helps toimpart strength to the cup so that it is less likely to deform when itis being forced into the prepared bone of a patient. As it is desirableto have a tight, and therefore secure, fit of the cup in the bone, it iscommon for a surgeon to hit the cup into place with a hammer or similarinstrument. However, in the case of hip resurfacing, it common to usethin-walled cups and it will therefore be understood that directlyhitting such a cup to insert it will have a high chance of damagingand/or deforming the cup. The present aspect of the invention thereforehelps to minimise this risk.

The impactor cap may be configured such that it is only possible tofully insert it into a cup if it is presented in one particularorientation with respect to the cup. This can help to ensure that thesurgeon inserts the cup into the patient in the correct orientation.

In one embodiment the acetabular cup prosthesis is provided with aninferior cut-out and the flange of the impactor cap will therefore beshaped to include said cut-out.

A location means may be provided for attachment of an introducer to theimpactor cap. The location means may be configured such that it is onlypossible to correctly attach the introducer to the impactor cap if it ispresented in one particular orientation with respect to the impactor cap(and therefore the cup).

In an embodiment the location means may be constituted by a rotationallyconstrained recess. In another embodiment the location means may beconstituted by a rotationally constrained projection.

According to an eleventh aspect of the present invention there isprovided an introducer for an acetabular cup prosthesis comprising amating means for mating with the cup; a gripping means for securing thecup to the introducer; and a handle for manipulating the position of thecup for insertion; wherein the mating means is configured to mate withthe cup in one orientation only.

As above, the present aspect of the invention helps to ensure that thesurgeon inserts the cup into the patient in the correct orientationsince it is not uncommon for a cup to be incorrectly inserted.

The mating means may be constituted by a rotationally constrained recessor projection configured for location with a cooperatively constrainedportion of a cup or an impactor cap, such as those defined above.

In one embodiment the mating means may be constituted by an impactor capin accordance with an embodiment of the tenth aspect of the invention.In other words, the impactor cap may form an integral part of theintroducer.

The gripping means may be configured for co-operating with theattachment means of a cup, such as those defined above in relation tothe ninth aspect of the invention. Accordingly, the gripping means maycomprise one or more hooks, clamps, projections having a serratedsurface or devices for locking onto a serrated surface. The grippingmeans may further comprise a tensioning means for tightening the grip onthe attachment means so as to more securely fasten the cup to theintroducer.

The handle may include a kink to navigate around a portion of thepatient's body when inserting the cup into position. It will beunderstood that when the cup, the impactor cap and the introducer areall fixed together, it is not possible for the surgeon to insert the cupupside down as the kink in the introducer handle physically preventsthis. The handle may be provided with an end suitable for hitting with ahammer or similar instrument to force the cup into position. The end maybe arranged to be perpendicular to the axis of the pole of the cup so asto transmit a force applied to it through the axis of the cup. Where theinner diameter of the cup is displaced with respect to the outerdiameter of the cup, the axis of the cup will be taken to be that inrelation to the outer surface of the cup, in this instance.

According to a twelfth aspect of the present invention there is provideda prosthesis having an external surface provided with a rough exteriorto aid initial fixation; a porous structure for bone in-growth; and aplurality of undercuts to allow bone to lock onto the surface.

In the case of thin-walled acetabular cup prosthesis, such as thoserequired for hip resurfacing, it has been found that traditional,aggressive (e.g. 2 mm squeeze) press-fit techniques are unsuitablebecause the wall of the cup is not strong enough to withstand thecompressive forces applied in this instance. Accordingly, it isnecessary to employ another mechanism to fix the cup in position.

The present aspect of the invention provides a suitable fixation meansfor a prosthesis by including a rough (e.g. sharp-edged) exteriorsurface which can provide good primary fixation in the bony bed,including a porous structure which is bio-acceptable so as to allow boneto grow onto and into the surface of the prosthesis and undercuts sothat in-grown bone can extend into these regions to develop a mechanicallock onto the implant.

Providing a porous external surface is one technique that has previouslybeen employed to aid fixation of prosthesis. Such a porous surface hasbeen achieved by gluing wax/polymer beads onto a surface of awax/polymer facsimile of a prosthesis and by using the so-calledlost-wax technique of creating a solid ceramic encasement around theresulting wax/polymer facsimile, melting and removing the wax/polymerfrom the ceramic, pouring molten metal into the resulting cavity,allowing the molten metal to solidify and then breaking the ceramicencasement (and dissolving the ceramic in the metal undercuts byleaching the material in a strong alkali) to release a solid metalimplant having a beaded external surface. Whilst it has been found thatsuch a beaded surface does permit bone in-growth (over time) topenetrate between adjacent beads to latch onto the prosthesis, the factthat the beads are generally spherical and therefore only have a single,smooth point of contact with the surrounding bone on insertion meansthat there is little frictional resistance to hold the implant in place.The present aspect of the invention addresses this problem by includinga rough (e.g. sharp) surface to increase the frictional resistancebetween the prosthesis and the surrounding bone so as to aid initialfixation of the implant.

An alternative known method of creating a porous surface includes gluinga layer of sponge-like structure (e.g. a 2 mm thick piece of reticulatedpolyurethane foam) onto a wax/polymer facsimile of a prosthesis andusing the lost-wax technique described above to create a metal castinghaving a sponge-like surface layer for bone in-growth. However, withthis technique it is necessary for the sponge-like structure to have athickness of at least 2 mm so as to provide structural integrity. As aconsequence, the thickness of the solid metal of the prosthesis isrequired to be made thinner to accommodate such a thick porous layer,thereby resulting in an overall weaker metal structure. In addition, ithas been observed that the interconnecting ‘fibres’ of the sponge-likestructure can be relatively thin leading to areas of imperfect fillingwith the molten metal and resulting in defects in the porous coating. Inorder to obviate this problem the molten metal has to be made lessviscous than normal by increasing the melt temperature. However, thedownside of this temperature increase is that it increases the grainsize of the resulting cast metal, which weakens the material and canlead to fatigue failure and fracture in use. It is therefore an aim ofthe present invention to ameliorate these problems.

The porous structure of the present aspect of the invention may beformed by e-beam or laser sintering of powdered metal (e.g. titanium,titanium alloy or cobalt chrome). These techniques essentially build thestructure in layers and can be used to form features having microscopicdimensions.

Alternatively, the porous structure of the present aspect of theinvention can be formed using lost-wax casting or centrifugal casting ofmetal. Such casting techniques are likely to be more cost-effective thanthe above sintering techniques for large-scale production.

The porous structure may be constituted by a lattice. It will beunderstood that the term lattice is used throughout to denote a seriesof interconnecting or contacting parts including gaps therebetween. Thelattice may be formed as a repeating pattern of interconnected elements.This embodiment has the advantage of providing a homogeneous surfacehaving similar properties throughout. This therefore overcomes adisadvantage encountered in prior art prosthesis such as those describedabove, wherein, for example, discrete wax/polymer beads are required tobe individually glued to a wax/polymer facsimile of a prosthesis inorder to form a metal casting therefrom and the homogeneity of thebeaded surface therefore depends on the skill of the person applying thebeads. In addition, the interconnecting or touching structure of thelattice can impart mechanical resistance to bending thereby increasingthe strength of the prosthesis. This is particularly advantageous whenused on thin-walled components such as an acetabular hip resurfacing cuphaving a wall thickness of approximately 1 mm at least at the peripheryof the cup.

In certain embodiments, the lattice may be 0.25 to 1 mm in thickness,for example, 0.5 mm. The relatively thin nature of the lattice will helpto ensure that valuable structural support thickness of the main body ofthe prosthesis will not need to be sacrificed to accommodate the porousstructure.

The lattice may comprise a plurality of posts radially extending fromthe exterior surface of the prosthesis, the posts supporting a series ofinterconnected bridging elements. Two or more types of posts may beprovided, each having a different transverse cross-section. In oneembodiment, a first set of posts may have a circular cross-section and asecond set of posts may have a multi-lobed cross-section (e.g. atriple-lobed cross-section). Each post in the first set of posts may bearranged to support mating ends of a plurality of bridging elements. Inone embodiment, each post in the first set of posts may be arranged tosupport mating ends of six bridging elements. Each bridging element mayextend radially from the first post to a lobe of one of the second setsof posts. Each of the second set of posts may be arranged to supportmating ends of a plurality of bridging elements, one extending from eachof its lobes. Accordingly, in an embodiment where each circular postsupports six bridging elements and each lobed post supports threebridging elements, a tessellating pattern is created with gaps (i.e.cavities) forming between the bridging elements which are in the shapeof 4-sided diamonds. The lattice may be configured such that the diamondholes may have a diameter of 0.1 to 1.0 mm, for example, 0.5 mm.However, it will be understood that many different latticeconfigurations could be conceived in accordance with this aspect of thepresent invention.

It will be understood that the supported lattice structures describedabove not only allow bone in-growth through the gaps (e.g. diamondholes) between the bridging elements but also provide undercuts in theregions underneath the bridging elements, between the posts, into whichbone can grow to mechanically lock the implant in place.

The lattice structure described above could be injection moulded inflexible plastic before the posts are glued to the exterior surface of awax/polymer facsimile of the prosthesis. The lost-wax techniquedescribed above could then be employed to allow metal to flow throughthe posts and into the bridging elements to create the metal castingincluding the lattice in its exterior surface.

In specific embodiments, the posts may be 0.5 to 1.5 mm in diameter, forexample, 1.0 mm. These relatively wide elements will permit easy flow ofmaterial into the lattice during a casting process, so that completefilling of a mould can be achieved at normal casting temperatures (i.e.without requiring higher than normal melt temperatures resulting in aweakening of the material cast).

The bridging elements may also have a relatively thick cross-section(e.g. 0.5 to 1.5 mm wide and 0.2 to 0.5 mm thick) for the same reason asabove. In a particular embodiment, the bridging elements may have awidth of 0.7 mm and a thickness of 0.3 mm.

The rough exterior may be provided on the lattice by including cut-outsin the exterior surface of the bridging elements. For example, diamondor pyramid shaped cut-outs can be provided so that multiple sharp edgesare presented to the bone for primary fixation of the implant. Thecut-outs could be created by including the desired shapes in theinjection mould tool for the lattice.

Alternatively, a rough exterior could be applied to the lattice byapplying a plasma spray coating to the injection mold tool or sandblasting the injection mold tool to give the lattice and hence the finalcast implant a rough outer surface.

In another embodiment, the lattice may comprise a plurality of touchingtruncated beads. The advantage of truncating the beads is that a largersurface area is provided for initial contact to a prepared bony cavity.Each bead may be truncated horizontally through its centre so as topresent its largest surface area to the bone. The truncated surface ofeach bead may have a diameter of approximately 0.2 mm to 2 mm.

The truncated surface of each bead may be provided with a plurality ofmicro-spikes to provide the rough exterior to the prosthesis. Thesemicro-spikes will enable better grip of the bone on insertion, therebyreducing the need for a press-fit fixation which is unsuitable for usewith thin-walled components.

Each micro-spike may have a diameter of approximately 0.5 mm or less.

In certain embodiments, each bead may be provided with 3 to 50micro-spikes (depending on the size of each bead and each micro-spike).In one embodiment, each bead is provided with 7 micro-spikes.

The external surface of the prosthesis may be formed of metal. Theporous structure, undercuts and rough exterior may also be formed ofmetal and may be integrally formed with the external surface of theprosthesis.

The prosthesis may be configured as an acetabular cup. The acetabularcup may comprise a metal outer she!] and a polymer inner liner, theexternal surface of the prosthesis being constituted by the externalsurface of the metal outer shell.

In addition to the methods described above for casting a metal shellwith an integral porous coating it is also possible to make a ceramicmould shell with an integral porous layer by Virtual Pattern Castingwhereby a mould is built up directly in ceramic including the bulkimplant and the integral porous surface layer. The mould can then befilled (preferably under pressure) using centrifugal casting but othercasting methods can optionally be employed.

In embodiments of the present invention, a (vacuum or non-vacuum) plasmasprayed metal (e.g. titanium) coating may be employed to provide aporous structure for bone in-growth and/or undercuts (between the metalparticles) to allow bone to lock onto the surface.

However, it has been discovered that such a coating can dislodge(although a vacuum plasma sprayed coating is thought to be less prone tothis) and it is difficult to obtain a really rough surface with thistechnique. Accordingly, in certain embodiments, the applicant proposesto employ (e.g. laser or e-beam) sculpturing of the external surface ofthe prosthesis to create a plurality of spikes which can be maderelatively sharp and can provide a rough surface which is good forinitial fixation of the prosthesis, prior to applying a (vacuum ornon-vacuum) plasma sprayed metal coating to provide undercuts and a goodpore size for bone in-growth.

Laser and e-beam sculpturing of metal surfaces is known (for example, asdescribed on the website of The Welding Institute (TWI) in relation totheir so-called Surfi-Sculpt® technique). Essentially, the sculpturingis performed by using a laser/e-beam to melt a small droplet of metal onthe surface. The laser/e-beam is then moved a small distance in atransverse direction (approximately parallel to the metal surface) sothat the droplet of metal is pushed out of the melt pool and allowed tosolidify into a protruding spike which may be approximately 0.5 mm inheight.

It is believed that an additional advantage of the present embodiment isthat by creating a spiky surface before plasma spraying, it is possibleto improve the bonding of the sprayed metal particles. This is becauseit has been observed that, under normal circumstances, (i.e. when aplasma sprayed coating is employed without spikes) it is common for themetal particles to be sheared off the prosthesis when it is press-fittedinto a patient. However, by having a sculptured (i.e. spiked) surfaceunderlying the sprayed coating, it is hoped that the shear forcespreviously causing particle dislodgment will be converted intocompressive forces making the particles much less likely to dislodge.

It will be understood that the various features described above inrelation to the fifth to eleventh aspect of the present invention may becombined with any of the features described above in relation to thetwelfth aspect of the invention, and vice versa.

The thickness of the metal shell defined in any of the described aspectsof the invention may be taken to include both the thickness of the shellitself and the thickness of the external surface provided on that shell(including the porous structure, undercuts and rough exterior of thepresent aspect of the invention).

A further embodiment of the sixth aspect of the invention iscontemplated wherein the exterior surface of the metal outer shell isconstituted in accordance with the present aspect of the invention andthe mechanical means attaching the metal outer shell to the polymerinner liner is in the form of a plurality of undercut spheres providedin the inner surface of the metal shell and extending into a solidportion of the porous structure. Thus, the undercut spheres for polymerattachment may be configured to extend into the posts or beads of alattice porous structure as defined above. This configuration isparticularly advantageous in minimising the thickness of the metal shellwhilst maintaining its integrity and strength.

It will be noted that in embodiments of the present aspect of theinvention, the porous structure, undercuts and rough exterior may notextend over the entire external surface area of the prosthesis. Inparticular, a rim of solid metal may be provided around the edge of themetal shell, where the metal may be thinnest. This rim of solid metalmay vary in width around the edge of the shell. In particular, the rimmay be widest (e.g. 3-4 mm) around the supero-lateral edge (oftenreferred to as either the superior edge or the lateral edge) of theshell and narrowest (e.g. 1-2 mm) around the inferior edge of the shell.This additional rim width is advantageous for support since it is commonto have no bone covering the supero-lateral edge of the cup (e.g. at 40to 45 degrees of inclination).

Furthermore, the exterior surface of the prosthesis may be configuredsuch that the porous structure is contained within the metal shell sothat the rough exterior is substantially flush with any portions notincluding a rough exterior, such as the rim defined above and thestrengthening ribs defined in relation to the seventh and eighth aspectsof the invention.

In certain embodiments, strengthening ribs may be provided on theexterior surface of the cup to butt against a moulding tool, thuspreventing crushing of the porous structure between the ribs.

The prosthesis of the present aspect of the invention may be configuredas a hip resurfacing femoral component, or a femoral stem for use intotal hip replacement.

In other embodiments, the prosthesis of the present aspect of theinvention may be configured as a femoral component or a tibial componentfor use in knee replacement techniques.

In yet further embodiments, the prosthesis of the present aspect of theinvention may be configured as any uncemented implant such as ashoulder, spinal, elbow, wrist, finger, ankle or toe implant.

According to a thirteenth aspect of the present invention there isprovided a prosthesis having an external surface provided with an arrayof fixation spikes configured to penetrate into a prepared bone cavity.

The fixation spikes may be configured to penetrate the bone by a depthof 2 mm or so. Notably, it is desirable that no holes are cut in to thebone cavity to accommodate the spikes prior to their insertion. Thespikes are therefore configured to penetrate into the bone simply onimpaction of the prosthesis. Accordingly, the fixation spikes canfunction as a primary fixation means negating the need for an aggressivepress-fit of the prosthesis which can cause deformation, particularly ofthin-walled components.

The array may comprise 10 to 500 fixation spikes, for example, 100 or200.

The array may be formed as an integral part of the external surface ofthe prosthesis.

Each fixation spike may have a height of approximately 2 mm. In someembodiments, the height of the fixation spikes may vary. For example,the fixation spikes at the edge of the array may be of a minimum height(e.g. 0.5 mm) with the height of the fixation spikes graduallyincreasing towards the centre of the array. At the centre the spikes maybe 2 mm in height.

The spikes may be conical in shape, terminating in a sharp point.

The prosthesis may be configured as an acetabular cup. The acetabularcup may comprise a metal outer shell and a polymer inner liner, theexternal surface of the prosthesis being constituted by the externalsurface of the metal outer shell.

The array may be located on the most proximal region of the cup (asdefined with reference to the body of the patient) when orientated readyfor insertion. Thus, on impaction the spikes are the first portions ofthe cup to contact the bone and therefore they are able to be forcedinto the bone before the remainder of the cup contacts the bony cavityand prevents any further penetration.

Each fixation spike may point parallel to the axis of the pole of thecup, when viewed from the inferior side of the cup, and parallel to theaxis of insertion of the cup into the bone.

It will be understood that the various features described above inrelation to the fifth to twelfth aspects of the present invention may becombined with any of the features described above in relation to thethirteenth aspect of the invention, and vice versa.

A further embodiment of the eighth aspect of the invention iscontemplated wherein the exterior surface of the metal outer shell isconstituted in accordance with the present aspect of the invention andthe fixation spikes are provided on the thicker region of the metalshell (adjacent the pre-determined wear zone).

According to a fourteenth aspect of the present invention there isprovided a prosthesis having an external surface provided with at leastone fixing means configured for the exterior attachment of a modularpeg.

Thus, the present aspect of the invention provides a means forselectively attaching a peg to prosthesis from the exterior thereof. Itis known to provide pegs on prosthesis such as acetabular cups byscrewing the pegs into position by inserting them through an interiorsurface of the cup. It is, however, envisaged that embodiments of thisaspect of the invention will be in the form of an acetabular cupprosthesis having a metal outer shell mechanically connected to apolymer inner liner such that attaching a peg to the prosthesis is notpossible from the interior of the cup.

It will be understood that the provision of a peg extending from theprosthesis will limit the final position of the prosthesis and so it isimportant that the hole prepared in the bone to accommodate the peg isin the correct position. Commonly, the position of any holes requiredfor pegs would be determined using a trial prosthesis such as a trialacetabular cup, which is also used to check that the cavity created forthe cup is of the correct size. Generally, trial cups are configured forline-to-line fit within the bone cavity (or a very slight press-fit).They are also provided with a smooth exterior surface so that they canbe removed from the cavity relatively easily (i.e. without muchfrictional resistance). Since the trial cup is not a tight press-fit inthe acetabulum, it is possible to attach to the trail cup a navigationdevice or alignment device (such as that described the Applicant'sco-pending US-2008-0269757-A1). When the correct position of the trialcup has been achieved, the holes for the one or more pegs are drilled.These holes guide the pegs on the definitive implant to achieve aperfect position, without the need for an alignment or navigation deviceto be used on the definitive cup.

If the cavity is determined to be a good fit for the trial cup, thesurgeon may decide that no modular pegs are required for additionalfixation and so the prosthesis may be inserted without the modular pegsbeing attached. This is the ideal situation. However, if the trial cupis determined not to provide such a good fit, the surgeon may decidethat additional fixation is required and, in which case, he/she canselect to attach one or more modular pegs to the prosthesis and to drillthe required holes through corresponding holes provided in the trailcup.

The fixing means may be constituted by a cavity having an internalscrew-thread. In which case, the modular pegs would include a basehaving a complementary external screw thread. The cavity may have aclosed end to prevent debris or tissue from passing through the externalsurface of the prosthesis and causing damage within. Where an innerpolymer liner is provided, the closed end will also help to support thepolymer layer which may be thin in this region. In addition, the closedend will prevent any polymer debris from migrating into the bone of thepatient's acetabulum, which could lead to osteolysis.

A filling may be provided to substantially fill the cavity of the fixingmeans if the modular peg is not required. The filling may be in the formof a grub screw having an external screw thread to mate with that of thefixing means and a relatively small recess in its top surface forlocation of a tool (such as a screwdriver or Allen key) to selectivelyremove the filling.

Each modular peg may be conical in shape, terminating with a roundedtip.

The modular pegs may include one or more notches to aid grip whenattaching them to the fixing means.

In a particular embodiment two fixing means and modular pegs areprovided.

The prosthesis may be configured as an acetabular cup. The acetabularcup may comprise a metal outer shell and a polymer inner liner, theexternal surface of the prosthesis being constituted by the externalsurface of the metal outer shell.

The modular pegs (and hence, their fixing means) may be located on themost proximal region of the cup (as defined with reference to the bodyof the patient) when orientated ready for insertion.

The modular pegs may extend in a direction normal to the externalsurface of the cup. This is advantageous in that it allows for a maximumthickness of the cup (e.g. of the metal shell of the cup) for anchoringthe modular pegs in the fixing means. However, it will be understoodthat when more than one peg extends in a direction normal to the curvedsurface of the cup, they will effectively diverge making insertion intothe prepared bone impossible unless the outer sides of the pegs areeither parallel or converging. Thus, conical pegs may be used for easeof insertion.

Where two conical modular pegs are provided, they may be configured suchthat each of their outer edges are parallel or converging. In this case,the conical shape means that the cup (and therefore the pegs) areinsertable in a straight line even though the pegs have a diverging longaxis (e.g. when viewed from the inferior edge).

It will be understood that the various features described above inrelation to the fifth to thirteenth aspects of the present invention maybe combined with any of the features described above in relation to thefourteenth aspect of the invention, and vice versa.

A further embodiment of the eighth aspect of the invention iscontemplated wherein the exterior surface of the metal outer shell isconstituted in accordance with the present aspect of the invention andthe modular pegs are provided on the thicker region of the metal shell(adjacent the pre-determined wear zone).

According to a fifteenth aspect of the present invention there isprovided a prosthesis having an external surface fitted with at leastone permanent peg.

Thus, the present aspect of the invention provides a prosthesis having apeg permanently fixed to an outer surface thereof. This is possible withthe present invention since it is envisaged that a trial cup will beused to determine the exact location of the peg(s) so that location ofthe peg(s) into holes created with the trail cup in the correct positionwill guide the prosthesis into the correct location with no furtheralignment required.

The at least one peg may be formed separately from the remainder of theprosthesis and then permanently fitted thereto (e.g. by gluing orwelding). Alternatively, the at least one peg may be integrally formedwith the prosthesis.

Each peg may be conical in shape, terminating with a rounded tip.

In a particular embodiment two pegs are provided.

The prosthesis may be configured as an acetabular cup. The acetabularcup may comprise a metal outer shell and a polymer inner liner, theexternal surface of the prosthesis being constituted by the externalsurface of the metal outer shell.

The at least one peg may be located on the most proximal region of thecup (as defined with reference to the body of the patient) whenorientated ready for insertion.

The at least one peg may extend in a direction normal to the externalsurface of the cup. This is advantageous in that it allows for a maximumthickness of the cup (e.g. of the metal shell of the cup) for anchoringthe peg in the fixing means. However, it will be understood that whenmore than one peg extends in a direction normal to the curved surface ofthe cup, they will effectively diverge making insertion into theprepared bone impossible unless the outer sides of the pegs are eitherparallel or converging. Thus, conical pegs may be used for ease ofinsertion.

Where two conical pegs are provided, they may be configured such thateach of their outer edges are parallel or converging. In this case, theconical shape means that the cup (and therefore the pegs) are insertablein a straight line even though the pegs have a diverging long axis (e.g.when viewed from the inferior edge).

It will be understood that the various features described above inrelation to the fifth to thirteenth aspects of the present invention maybe combined with any of the features described above in relation to thefifteenth aspect of the invention, and vice versa.

A further embodiment of the eighth aspect of the invention iscontemplated wherein the exterior surface of the metal outer shell isconstituted in accordance with the present aspect of the invention andat least one peg is provided on the thicker region of the metal shell(adjacent the pre-determined wear zone).

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will now be described withreference to the accompanying drawings in which:

FIG. 1 illustrates schematically a cross-section through a proposedacetabular cup prosthesis having a relatively thin metal outer shell anda relatively thick polymer inner liner;

FIG. 2 shows a view similar to that of FIG. 1 but with the centre of thepolymer inner liner displaced with respect to the metal outer shell toas to allow for an increased cup thickness in a pre-determined wearzone, in accordance with a first embodiment of the present invention;

FIG. 3 shows a view similar to that of FIG. 2 but with a cut-outprovided at an inferior edge of the cup to compensate for thedisplacement of the inner liner;

FIG. 4 shows a view similar to that of FIG. 3, wherein thepre-determined wear zone of the articular bearing surface of the polymerliner is provided with cross-linked polymer bonds;

FIG. 5 shows a view similar to that of FIG. 4, but with aninterdigitised interface between the portion of the polymer linerprovided with cross-linked polymer bonds and the portion withoutcross-linked polymer bonds;

FIG. 6A shows a perspective view from a first side of an acetabular cupprosthesis in accordance with one embodiment of the invention, fittedwith an impactor cap in accordance with another embodiment of theinvention;

FIG. 6B shows a side elevation view of the acetabular cup and impactorcap of FIG. 6A;

FIG. 6C shows a part-perspective view of the acetabular cup and impactorcap of FIG. 6A, from a second side;

FIG. 6D shows a part-perspective view of the acetabular cup and impactorcap of FIG. 6A, showing a close-up of the cup edge and initial portionsof the introducer attachment loops;

FIG. 7 shows a part-perspective view of the acetabular cup shown inFIGS. 6A through 6D, without the impactor cap, but showing in detail thebase of one of the introducer attachment loops;

FIG. 8 shows a side part-perspective view of an acetabular cupprosthesis in accordance with a further embodiment of the invention,including serrated introducer attachment elements;

FIG. 9 shows a view similar to that of FIG. 8 but with an impactor capfitted to the cup;

FIG. 10 shows a side part-perspective view of a metal shell of anacetabular cup prosthesis in accordance with another embodiment of theinvention, including introducer attachment elements in the form ofprotruding metal rods;

FIG. 11 shows a view similar to that of FIG. 10 but with a polymer linermoulded into the metal shell and around the metal rods;

FIG. 12 shows a view similar to that of FIG. 11 but with an impactor capfitted to the cup;

FIG. 13 shows a view similar to that of FIG. 12 but with the ends of themetal rods fitted with conical portions at their tips;

FIG. 14A shows a top perspective view of the impactor cap shown in FIGS.6A-6D, 9,12 and 13;

FIG. 14B shows an underneath perspective view of the impactor cap ofFIG. 14A; FIG. 14C shows an underneath perspective view from a firstside of the impactor cap of FIG. 14A;

FIG. 14D shows an underneath perspective view from a second side of theimpactor cap of FIG. 14A;

FIG. 15A shows a simplified perspective view of an introducer inaccordance with an embodiment of the present invention;

FIG. 15B shows an end elevation view of the introducer shown in FIG.15A; FIG. 15C shows a side elevation view of the introducer shown inFIG. 15A;

FIG. 15D shows a part-perspective view of the end of the introducershown in FIG. 15A, configured for attachment to an impactor cap such asthat shown in FIGS. 14A-D;

FIG. 16A shows a side elevation view of the introducer shown in FIGS.15A-D inserted into an impactor cap similar to that shown in FIGS.14A-D, provided in an acetabular cup prosthesis similar to that shown inFIGS. 6A-D;

FIG. 16B shows the apparatus of FIG. 16A after tension has been appliedby the introducer to securely attach the acetabular cup thereto;

FIG. 17 shows a part-perspective view of an outer portion of anacetabular cup according to an embodiment of the present invention;

FIG. 18 shows a schematic illustration of an enlarged portion of anexternal surface of an acetabular cup according to one embodiment of thepresent invention;

FIG. 19 shows an internal view of a metal shell of an acetabular cupprosthesis according to an embodiment of the present invention, showingthe distribution of cut-outs for mechanical attachment of a polymerinner liner;

FIG. 20 shows a part cross-sectional view of an edge portion of anacetabular cup prosthesis according to an embodiment of the presentinvention, showing the mechanical attachment of a polymer inner liner inspherical cut-outs provided on an internal surface of a metal outershell, and wherein the metal outer shell comprises a plurality oftruncated beads on its external surface;

FIG. 21 shows an enlarged view of a truncated bead provided on theacetabular cup of FIG. 20;

FIG. 22 illustrates schematically a truncated bead having a sphericalcut-out protruding into it from an inner surface thereof, in accordancewith a particular embodiment of the invention;

FIG. 23 shows a part cross-sectional view of an edge portion of anacetabular cup prosthesis according to a particular embodiment of thepresent invention, showing the mechanical attachment of a polymer innerliner in spherical cut-outs provided on an internal surface of a metalouter shell, and wherein the metal outer shell comprises a plurality oftruncated beads on its external surface and into which the sphericalcut-outs protrude, however, as the section is not through the mid-pointof the beads, they appear not to be touching in this view;

FIG. 24A shows a part underneath plan view of an external surface of ametal shell for the acetabular cup of FIG. 17 including fixation meansfor modular pegs and fixation spikes for primary fixation to the bonybed but prior to inclusion of truncated beads; FIG. 24B shows a viewsimilar to that shown in FIG. 24A but with fillings provided in thefixing means;

FIG. 24C shows a view similar to that of FIG. 24A, rotated through 180°,and showing the modular pegs fitted in the fixation means;

FIG. 25A shows the configuration of FIG. 24C in an elevation view fromthe inferior end of the cup;

FIG. 25B shows the configuration of FIG. 24C viewed from above thecentre of the superior end of the cup;

FIG. 25C shows the configuration of FIG. 24C viewed from above the sideof the superior end of the cup;

FIG. 25D shows the configuration of FIG. 24C in an elevation view fromone side of the cup;

FIG. 26 shows a part cross-sectional view through the modular pegs ofFIG. 24C;

FIG. 27 shows a cross-sectional view similar to that shown in FIG. 26but showing the entire metal shell of the acetabular cup, includinginternal cut-outs for polymer attachment;

FIG. 28A shows an enlarged underneath plan view of a porous latticestructure for attachment to an external surface of a prosthesis such asan acetabular cup prosthesis according to an embodiment of the presentinvention;

FIG. 28B shows a further enlarged perspective view of a portion of thelattice structure shown in FIG. 28A;

FIG. 29A shows a top plan view of the lattice structure shown in FIG.28A;

FIG. 29B shows an enlarged top plan view of a portion of the latticestructure shown in FIG. 29A;

FIG. 29C shows an enlarged perspective view of a portion of the latticestructure shown in FIG. 298;

FIG. 29D shows a further enlarged perspective view of a first portion ofthe lattice structure shown in FIG. 29C;

FIG. 29E shows a further enlarged perspective view of a second portionof the lattice structure shown in FIG. 29C; and

FIG. 30A shows a perspective view of an acetabular cup prosthesisaccording to an embodiment of the invention, after a first layer of thepolymer liner has been moulded but prior to the moulding of a secondlayer forming a portion of the articular surface layer of the cup;

FIG. 30B shows a perspective view of the acetabular cup of FIG. 30Aafter the moulding of the second layer in the first layer to form aportion of the articular surface layer of the cup;

FIG. 31 shows a perspective view of an acetabular cup prosthesisaccording to a further embodiment of the invention, wherein a secondlayer of a polymer liner (forming a portion of an articular surfacelayer of the cup) has been moulded separately to a first layer of thepolymer liner, just prior to insertion of the second layer into thefirst layer;

FIG. 32 shows a perspective view of an acetabular cup prosthesisaccording to a another embodiment of the invention, wherein a secondlayer of a polymer liner (forming the whole of an articular surfacelayer of the cup) has been moulded separately to a first layer of thepolymer liner, just prior to insertion of the second layer into thefirst layer;

FIG. 33 shows a graph of the Bulk Oxidation Index (BOI) for three testsamples to compare the oxidation levels of a standard polymer componentwith those formed according to embodiments of the present invention; and

FIG. 34A shows a side perspective view of a one-piece acetabular cupprosthesis according to an embodiment of the present invention in whichthe centre of the inner surface has been displaced with respect to theouter surface and a cut-out provided at an inferior edge;

FIG. 34B shows a cross-sectional view through the one-piece acetabularcup prosthesis of FIG. 34A;

FIG. 35A shows a cross-sectional view through a metal acetabular cupshell, showing a series of holes through an edge rim of the shell, inaccordance with an embodiment of the present invention;

FIG. 35B shows an enlarged view of an edge portion of the metal shell ofFIG. 3513, showing that the cross-section has been taken through one ofthe holes;

FIG. 36A shows a cross-sectional view of the shell of FIGS. 35A and 35Bafter a polymer liner has been compression moulded therein;

FIG. 36B shows an enlarged view of an edge portion of the cup of FIG.36A, showing the polymer liner extending through the exposed hole in themetal shell;

FIG. 37A shows an enlarged cross-sectional view of a spike created in anexternal surface of a metal acetabular cup shell, in accordance with anembodiment of the present invention; and

FIG. 37B shows a view similar to that of FIG. 37A but after a vacuumplasma sprayed metal coating has been applied to the spiky surface.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

With reference to FIG. 1, there is illustrated a central cross-sectionof a proposed acetabular cup prosthesis 10 having a relatively thin(e.g. 1 mm) hemi-spherical metal outer shell 12 and a co-centredrelatively thick (e.g. 2 mm) hemi-spherical polymer inner liner 14. Inthis case, the polymer inner liner or shell 14 is glued by an adhesive(not shown) to the inner surface of the metal outer shell 12. It will benoted that inner diameter to outer diameter difference of the cup 10 is6 mm—the cup 10 having a thickness of 3 mm at each side.

While such a thin-walled acetabular cup prosthesis is desirable for hipresurfacing (where only a minimal amount of bone is removed toaccommodate the implant), it has been proposed that insertion of the cupusing a traditional 2 mm press-fit technique would lead to uncontrolleddistortion and damage to the cup. Various aspects of the presentinvention therefore aim to address this problem.

FIG. 2 shows a central cross-section of an acetabular cup prosthesis 20,which is similar to that shown in FIG. 1 but with the centre of thepolymer liner 24 displaced outwardly and downwardly (i.e. distally andinferiorly) with respect to the metal shell 22. This allows a greaterthickness of the polymer liner 24 to be provided in the region ofhighest wear (i.e. in the intended wear zone) which generally extendstowards the supero-lateral edge 26 of the cup 20 from slightly below thecentre of the cup 20.

As one aim of the present invention is to preserve as much bone aspossible, it is desirable not to increase the inner diameter to outerdiameter difference of the acetabular cup 20 as a result of thickeningthe polymer liner 24 in the intended wear zone. Thus, as illustrated itcan be seen that maintaining a 1 mm thick metal shell 22 and displacingthe polymer liner 24 to provide 4 mm of thickness at the supero-lateraledge 26 results in the polymer liner 24 having zero thickness at theinferior edge 28. Accordingly, the Applicant proposes to provide acut-out 30 along the inferior edge 28 of the cup 20 so as to negate thisproblem. As illustrated in later figures, the cut-out 30 is in the shapeof an arc extending from one side of the cup 20 to the other. Thecut-out 30 ensures an adequate thickness of polymer liner 24 covers theinner, articular surface of the metal shell 22 so as to prevent wear ofthe metal shell 22 in use. In addition, the cut-out 30 provides a usefulreference point for the surgeon to help in the orientation of the cupfor correct placement (e.g. to ensure the cup is not inserted upsidedown).

FIG. 3 shows a cup 40 according to an embodiment of the invention. Thecup 40 is similar to that shown in FIG. 2 but with the cut-out 30removed from the inferior edge 28. In addition, the metal shell 22 ofthe cup 40 is provided with inwardly inclined bevelled edges 42 and thepolymer liner 24 is provided with a rounded edge 44 that extends overthe edges 42 of the metal shell 22 to ensure no sharp edges are exposedto the patient or surgeon. Furthermore, it is advantageous to cover themetal edges 42 with the polymer edge 44 so as to prevent the metal shell22 from scratching the femoral head in use, particularly in the event ofinadvertent subluxation or dislocation.

FIG. 4 shows a cup 50 according to another embodiment of the invention.The cup 50 is similar to that shown in FIG. 3 but wherein apre-determined wear zone 52 of the polymer liner 24 is provided withcross-linked polymer bonds. As discussed above, the wear zone 52 isprovided in the region of maximum thickness of the polymer liner 24, thezone extending generally towards the supero-lateral edge 26 of the cup50 from slightly below the centre of the cup 50. As illustrated, thecross-linked polymer bonds may penetrate into the polymer liner 24 inthe shape of a part-spherical disc having a thickness which is at amaximum at its centre and tapers smoothly outwardly to a minimumthickness around its edges. Importantly, only a portion of the articularbearing surface of the cup 50 is cross-linked (i.e. in the wear zone)such that the remainder of the surface of the polymer liner 24 is notcross-linked. This helps to maintain the strength of the conventionalpolymer (in this case, polyethylene) throughout the majority of thepolymer liner 24 and particularly in the thinnest and therefore morefragile regions of the polymer liner 24 while ensuring that the wearzone is modified by the cross-linked bonds to reduce the risk of wear.

The polymer liner 24 of the cup 50 of the present embodiment was formedby cold compressing a first layer of polyethylene powder including 2% ofvitamin E to form a bulk layer and cold compressing a second layer ofpolyethylene powder including less than 0.2% vitamin E to form the wearzone. The powders of the first and second layers were then melted by hotcompression moulding to form a single solid component.

Next, the component was irradiated (to provide approximately 100 kGy ofabsorbed radiation) so as to cross-link the molecules in the secondlayer; the molecules in the first layer being prevented fromcross-linking due to the higher concentration of vitamin E. Lastly, thecomponent was annealed by heating it below its melting point so as toencourage the vitamin E in the first layer to diffuse into the secondlayer to consume free radicals therein and thereby minimise the risk ofoxidation of the second layer.

FIG. 5 shows a cup 60 according to a further embodiment of theinvention. The cup 60 is similar to that shown in FIG. 4 but with aninterdigitised interface 62 provided between the portion of the polymerliner 24 provided with cross-linked polymer bonds, also referred to asthe wear zone 52, and the portion without cross-linked polymer bonds.The interdigitised interface 62 is provided by a series of spikes 64 ofcross-linked polymer 52 which project into corresponding recesses in thenon cross-linked polymer. The aim of the spikes 64 is to break up anotherwise sharp transition between the two types of polymer so as toprovide a smoother transition between the two mechanical properties ofthe polymers to thereby reduce the risk of de-lamination at theinterface 62.

The polymer liner 24 of the cup 60 may be formed in a similar way tothat described above in relation to the cup 50 of FIG. 4. However, thistime the step of cold compressing the first layer of polymer includesstamping the recesses in the first layer, in the region of the wearzone, and the step of cold compressing the second layer of polymerincludes filling the recesses with the powder for the second layerbefore stamping the shape of the articular surface of the cup 60.

FIGS. 6A through 6D show various views of an acetabular cup prosthesis70 in accordance with a particular embodiment of the invention, fittedwith an impactor cap 72 in accordance with another embodiment of theinvention. The acetabular cup 70 is essentially as shown in FIG. 4 butincluding further features on the external surface of the metal shell 22for improved fixation in a prepared bone cavity. The external surface ofthe metal shell 22 is more clearly illustrated in FIG. 17 and so will bedescribed in more detail below. In addition, the cup 70 shown in FIGS.6A through 6D includes two relatively large polymer loops 74 extendingfrom the edge of the polymer liner 24.

These loops 74 are configured as a means for attaching the cup 70 to anintroducer configured for inserting the cup 70 into a patient. Someexamples of suitable introducers are shown in FIGS. 15A through 15D andFIGS. 16A and B and will be described in more detail below.

In the embodiment shown in FIGS. 6A through 6D, each loop 74 isintegrally moulded to the polymer liner 24. In addition, each loop 74has a first end 76 located at the inferior end 28 of the cup 70 (i.e. inthe region of the cut-out) and a second end 78 located at the opposite,supero-lateral end 26 of the cup 70. Notably, the loops 74 are thickestat their first and second ends 76, 78 so as to provide more support atthese joints.

It will be understood that after insertion of the cup 70 into a patient,the loops 74 will be removed by cutting the first and second ends 76, 78from the polymer liner 24 so as to leave the polymer liner 24 with arelatively flush, smooth surface.

The impactor cap 72 in FIGS. 6A through 6D is shown in more detail inFIGS. 14A through 14D. However, as can be seen from the present figures,the impactor cap 72 is designed to fit within the cup 70 and has aflange 80 around its peripheral edge which is shaped to rest on the edge44 of the polymer liner 24. Thus, the impactor cap 72 is shaped to takeaccount of the cut-out at the inferior edge 28 of the cup 70. The flangeis also provided with four semi-circular cut-outs 82, one around each ofthe first and second ends 76, 78 of the loops 74 so as to allow theloops 74 to project outwardly from the edge 44 of the polymer liner 24.In addition, the impactor cap 72 includes a location means in the formof a recess 84 which is shaped such that a cooperating projection canonly be received in the recess 84 in one orientation. In thisembodiment, the recess 84 comprises a straight side 86 and a curved side88 which together form the outline of a capital D. The recess 84 isprovided so that it is only possible for a surgeon to attach anintroducer to the cup 70 in the correct orientation as will be describedin more detail below.

FIG. 7 shows an enlarged view of a portion of the cup 70 without theimpactor cap 72. More specifically, FIG. 7 shows an enlarged view of thefirst end 76 of one the loops 74, showing the increased thickness inthis region. Thus, it can be seen that in this embodiment, the first end76 (and the second end 78, not shown) has the form of a frusto-conicalfoot which is thickest at its base.

FIG. 8 shows an acetabular cup prosthesis 90 having an alternativeattachment means in the form of four polymer bands 92 projecting fromthe edge of the polymer liner 24. The bands are integrally formed withthe polymer liner 24 and include a serrated outer surface 94 towardstheir free ends. It will be understood that each of the serratedsurfaces 94 are configured for use with a device configured to lock ontothe serrations, much like in the form of a traditional cable tie. Thedevice for locking onto the serrations will be provided on an introducerconfigured for use with the cup 90. Ideally, the device will beconfigured to allow the serrated surface 94 to be passed through it inone direction but to prevent the serrated surface 94 from passingthrough it in the opposite direction. As before, when the cup 94 is inposition, the bands 92 will be cut from the polymer liner 24 to leave asmooth external surface.

FIG. 9 shows the cup 90 of FIG. 8 fitted with the impactor cap 72 asdescribed above. It is clear from this view that the impactor cap 72will only fit onto the cup 90 one way due to the angling of the flange80 which accommodates the cut-out at the inferior edge of the cup 90. Asabove, the four semi-circular cut-outs 82 in the flange 80 allow theattachment means (in this case the bands 92) to project outwardly fromthe edge 44 of the polymer liner 24.

A further attachment means is shown in FIGS. 10 to 12 in a furtheracetabular cup 100 according to another embodiment of the invention. Inthis case the attachment means is in the form of four metal rods 102.The metal rods 102 may be integrally formed with the metal shell 22 asshown in FIG. 10. Each rod 102 includes a shaft 104 having a largespherical ball 106 mounted on its free end. Close to the interfacebetween the rod 102 and the metal shell 22, there is provided a neck 108which is thinner than the rest of the shaft 104. The neck 108 isprovided so that after the cup 100 has been inserted into a patient, therod 102 can be twisted to cause the neck 108 to break and thereby enablethe depending portion of the rod 102 to be removed. Although not shown,it will be understood that the cup 100 is configured for use with anintroducer that can grip onto the spherical balls 106 to thereby securethe cup 100 to the introducer.

It will also be seen from FIG. 10 that the internal surface of the metalshell 22 is provided with a plurality of small spherical cut-outs 110.These are provided for the mechanical fixation of the polymer liner 24to the metal shell 22, as will be described in more detail withreference to FIG. 21A.

FIG. 11 shows a view similar to that of FIG. 10 but with the polymerliner 24 attached to the metal shell 22. Thus, it can be seen that thepolymer liner 24 is formed around the base of the rods 102 such that therods 102 project from the polymer liner 24. Notably, the necks 108 arebelow the surface of the polymer liner 24 so that when the rods 102 areremoved, the remaining portions of the shafts 104 are encapsulated bythe polymer liner 24 so as to protect the surrounding tissue from damageby these parts.

The cup 100 is shown in FIG. 12 with the impactor cap 72 in place. Aspreviously, the four semi-circular cut-outs 82 in the flange 80 allowthe attachment means (in this case the rods 102) to project outwardlyfrom the edge 44 of the polymer liner 24.

FIG. 13 shows another acetabular cup prosthesis 112, according to anembodiment of the present invention, also fitted with the impactor cap72. In this case, the attachment means is identical to that shown inFIGS. 10 to 12 except that the spherical balls 106 on the ends of eachshaft 104 are replaced by a generally conical structure 114. The conicalstructure 114 is composed of a series of three conical portions 116stacked with their tips towards the free end of the rod 102, eachconical portion 116 decreasing in size toward the free end of the rod102.

In alternative embodiments, the necks 108 may not be provided in therods 102 and the rods 102 may simply be cut adjacent the polymer liner24 when they are to be removed.

FIGS. 14A through 14D show various views of the impactor cap 72 firstintroduced in relation to FIG. 6A. Thus, it can be seen that theimpactor cap 72 includes a large bulbous exterior surface 89 on itsunderside which is shaped to precisely match the shape of inner surfaceof the polymer liner 24. Accordingly, the impactor cap 72 providesadditional strength to any thin-walled acetabular cup, such as thosedescribed above in accordance with different embodiments of the presentinvention, and therefore helps to maintain the shape of the cup as it isimpacted into a prepared bone cavity, even where a slight press-fit isrequired.

FIGS. 15A through 15D show various views of an introducer 120 accordingto one embodiment of the present invention. The introducer 120 includesa mating means in the form of a projection 122 that is configured to fitinto the recess 84 of the impactor cap 72 when inserted into anacetabular cup such as those described above. Thus the projection 122has a straight side 124 configured to mate with the straight side 86 ofthe recess 84 and a curved side 126 configured to mate with the curvedside 88 of the recess 84. Accordingly, it is only possible for theintroducer 120 to be attached to the impactor cap 72 in one orientation.As explained above, since the impactor cap 72 is itself only capable ofbeing attached to a cup in one orientation, this ensures that the cup isalways held on the introducer 120 in the correct orientation forinsertion into a patient.

The projection 122 extends from a head 128 of the introducer 120, whichitself is mounted on the end of a handle 130. The handle 130 is providedwith a kink 132 to avoid impingement with the body of the patient duringinsertion. The handle 130 is also provided with a cylindrical grip 134having an end 136 suitable for hitting with a hammer or similarinstrument to force the cup into position. The grip is aligned with theaxis of the cup such that the end 136 is orthogonal thereto and istherefore configured to transmit a force applied to it through the axisof the cup.

The introducer 120 also includes a gripping and tightening means forlocking onto the attachment means of a cup to secure it to theintroducer. This means has been omitted from FIGS. 15A through D forclarity but is shown in FIGS. 16A and B described below.

In an alternative embodiment, not shown, the impactor cap 72 may beintegral with the head 122 of the introducer 120.

FIG. 16A shows a side elevation view of the introducer 120 inserted intothe impactor cap 72, which in turn is inserted into an acetabular cupprosthesis 70 similar to that shown in FIGS. 6A-D but further includinga modular peg 140 as will be described in more detail below in relationFIG. 17. More specifically, the projection 122 of the introducer 120 islocated within the recess 84 of the impactor cap 72 and the bulgingsurface of the impactor cap 72 is placed into contact with the innerpolymer liner 24 of the cup 70. The flange 80 of the impactor cap 72 islocated on the edge 44 of the polymer liner 24 and the loops 74 arearranged to extend past either side of the head 128 of the introducer120.

As shown in FIGS. 16A and B, the introducer includes a gripping andtightening means 142 for locking onto the loops 74 of the cup 70. Themeans 142 includes two opposed feet 143, each provided with a projectingear 144 arranged such that each loop 74 can be wound around an ear 144to retain the loops 74 thereon. The means 142 further includes atightening mechanism 146 which, as shown in FIG. 1613, retracts the feet143 and ears 144 away from the head 128 on rotation of a thumb screw148. It will be understood that retracting the ears 144 also retractsthe loops 74 hooked thereon and as such tension is applied between thecup 70 and the introducer 120 so as to hold the cup 70 securely thereon.

FIG. 16B illustrates the assembly ready for insertion of the cup 70 intoa patient, after tension has been applied. As mentioned above, the cup70 may be impacted into the prepared bone by hammering the end 136 ofthe introducer 120. Once in position, the surgeon will release thetension by unscrewing the screw 148 to lower the feet 143. This in turnwill release the tension on the loops 74 allowing them to be disengagedfrom the ears 144. The introducer 120 and impactor cap 72 will then beremoved from the cup 70 and the loops 74 will be cut close the polymeredge 44.

FIG. 17 shows a part-perspective view of an outer supero-lateral portionof an acetabular cup 150 according to an embodiment of the presentinvention. The cup 150 is similar to that shown in FIGS. 6A to 6D and 7to 13. Accordingly, it includes a metal outer shell 22 and a polymerinner liner 24. The external surface of the metal shell 22 is providedwith a number of features to aid fixation of the thin-walled cup 150 ina prepared bone cavity. The majority of the surface is covered with atruncated-bead lattice 152 which is designed to sit on the surface ofthe bone cavity. The lattice 152 includes a rough exterior provided by aplurality of micro-spikes 154 which are configured to aid initialfixation by increasing the frictional resistance between the bone andthe cup 150. The lattice 152 also provides a porous structure for bonein-growth and a plurality of undercuts to allow bone to lock onto thecup 150. Each of these features will be shown in greater detail in laterfigures. The surface of the metal cup 22 is also provided with an arrayof conical fixation spikes 156 which are configured to penetrate intothe bone by approximately 2 mm so as to aid fixation in the absence of astrong press-fit which is not possible with such a thin-walled cup 150.The array is provided in a band across the most proximal region of thecup 150, as defined in relation to the body of the patient. Accordingly,on impaction the spikes 156 penetrate into the bone before the lattice152 contacts the surface of the cavity. The cup 150 is also providedwith two optional modular pegs 158 which are configured for selectiveattachment to the exterior of the metal shell 22 to provide additionalfixation, if required. The modular pegs 158 are provided on either sideof the centre of the array of fixation spikes 156. Each modular peg 158is conical and has a rounded tip. The modular pegs project normal to theexternal surface of the metal shell 22.

As seen in FIG. 17, the external surface of the metal shell 22 isprovided with a rim 160 around the periphery of the cup 150 which isfree from all of the above-mentioned fixation features. This isadvantageous in providing maximum strength around the periphery of thecup 150, particularly in the inferior region where both the metal shell22 and the polymer liner 24 are thin. Furthermore, a series ofstrengthening ribs 162 are provided in the region adjacent the peripheryof the cup 150. The strengthening ribs 162 extend in a longitudinaldirection towards the pole of the metal shell 22 and terminate close tothe array of fixation spikes 156, which it will be noted are provided inthe region of maximum thickness of the cup 150 (i.e. on the oppositesurface of the cup from the wear zone). The rim 160 and strengtheningribs 162 therefore help to stiffen the metal shell 22 in where it and/orthe polymer shell 24 are thinnest. In this particular embodiment, themetal shell 22 is configured to be approximately 1 mm thick around therim and in the region of the strengthening ribs 162 but becoming thickerto approximately 3 mm of thickness in the region adjacent the intendedwear zone. This increased thickness provided greater support for thefixation spikes 156 and modular pegs 158. Where the lattice 152 ispresent, the combined thickness of the metal shell 22 and the lattice152 is approximately 1 mm.

FIG. 18 shows a section of a particular truncated-bead lattice 152similar to that shown in FIG. 17. Thus, it can be seen that each bead164 is truncated so as to provide a large top surface layer onto which aplurality of conical micro-spikes 154 are provided. Notably, each bead164 is arranged to touch its nearest neighbours so that forces appliedto the beads 164 can be distributed through the lattice 152. The spacesbetween the beads 164 form a porous structure for bone in-growth and therounded sides of the beads 164 provide undercuts which allow bone togrow into to thereby lock onto the cup 150 in time.

FIG. 19 shows an internal view of the metal shell 22 of the cup 150.This shows the distribution of the spherical undercuts 110 provided inthe metal shell 22 for attachment of the polymer liner 24. Thus, it canbe seen that the undercuts 110 are smallest around the periphery of thecup 150 where the metal shell 22 is at its thinnest, becoming thickertowards the centre of the cup 150 where the metal shell 22 is thickest.In addition, no undercuts 110 are provided in the areas 166 opposite thestrengthening ribs 162 in order to preserve the strength of the metal inthese regions. Furthermore, no undercuts 110 are provided in the areas168 opposite to the location of the modular pegs 158. The reason forthis will become apparent in the discussion of later figures.

FIG. 20 shows a simplified schematic view of a part cross-sectional viewof a supero-lateral edge portion of an acetabular cup prosthesis 170according to a further embodiment of the present invention, which issimilar to that shown in FIG. 17. In this case the metal shell 22gradually increases in thickness towards its centre while the polymerliner 24 has its maximum thickness at this side of the cup 170 anddecreases in thickness towards the inferior side of the cup 1 70 (notshown). Spherical undercuts 110 are provided in the inner surface of themetal shell 22 into which the polymer liner 24 is compression moulded soas to mechanically attach the components together. As described above,the undercuts 1 10 are smallest at the edge of the metal shell 22 andbecome larger as the metal shell 22 increases in thickness. It will alsobe noted from FIG. 20 that the polymer liner 24 is provided as anextension from the end of the metal shell 22 and that the edge 172 ofthe polymer liner 24 is sloped outwardly so as to maximise the articularsurface area which would otherwise be reduced by the displacement of theinner liner 24 with respect to the metal shell 22.

A plurality of truncated beads 164 including micro-spikes 154 areprovided on the outer surface of the metal shell 22 as described above.Note the beads 164 shown in FIG. 20 are illustrative only. In practice agreat many beads 164 would be provided in touching relationship so as toform a lattice.

An enlarged view of a truncated bead 164 is shown in FIG. 21 along witha dashed spherical outline of the bead 164 prior to its truncation.

FIG. 22 illustrates schematically another truncated bead 164′ having aspherical cut-out 110 protruding into it from an inner surface of themetal shell 22 in accordance with another embodiment of the invention.

FIG. 23 shows another part cross-sectional view of a supero-lateral edgeportion of an acetabular cup prosthesis 180 according to a furtherembodiment of the present invention. In this case beads 164′ similar tothat shown in FIG. 22 are provided into which the spherical cut-outs 110in the metal shell 22 protrude. Thus, the polymer liner 24 ismechanically attached to the metal shell 22 by polymer nodules 182located within the spherical cut-outs 110. In this embodiment the edge44 of the polymer liner 24 is rounded.

FIGS. 24A, B and C show part underneath plan views of the externalsurface of the metal shell 22 for the acetabular cup 150 of FIG. 17including fixation means 190 for the modular pegs 158 and the fixationspikes 156 for primary fixation to the bony bed but prior to inclusionof the truncated-bead lattice 152. From each of these views, the band offixation spikes 156 appears to form a horseshoe shape with the modularpegs 158 encapsulated by the horseshoe. As described above, the fixationspikes 156 are provided in lieu of fixation normally obtained inthick-walled cups from heavy press-fit (e.g. by the acetabulum beingunder-reamed by 2 mm when compared to the cup outer diameter). Inembodiments of the present invention, where thin-walled cups areprovided, the reaming will preferably be a line-to-line fit with the cupouter diameter or, at most, a 1 mm press-fit may be applied. In eithercase, the fixation spikes 156 are arranged to project beyond the cupouter diameter so that they are necessarily driven into the reamedsurface of the acetabulum on cup impaction. As viewed in FIGS. 24A, Band C, the fixation spikes 156 are all in line with an axis through thecentre of the cup 150 and passing midway between the modular pegs 158.

The fixing means 190 for the modular pegs 158 each comprise a relativelythick metal support ring including a blind hole 192 provided with aninternal screw thread 194. Although not shown it will be understood thatthe underside of each modular peg 158 has a projection provided with anexternal screw thread for complementary engagement with the screw thread194. The fixation means 190 is a permanent feature of the metal shell 22and may be formed integrally therewith.

If the surgeon decides that additional fixation is not necessary, themodular pegs 158 will not be used and, instead, the holes 192 in thefixation means 190 will be provided with fillings 196. The fillings 196include an external thread so they can be screwed into the fixationmeans 190 and a hexagonal cut-out 198 for location of an Allen key sothey can be selectively removed (e.g. for the attachment of a modularpeg 158).

FIG. 24C shows the two modular pegs 158 screwed into the fixation meansof FIG. 24A. The modular pegs 158 shown in FIG. 24C are largely asdescribed in relation to FIG. 17. However, in the particular embodimentshown in FIG. 24C the modular pegs 158 include four equally spacedrecesses 200 for ease of grip when screwing or unscrewing the modularpegs 158 to/from the fixation means 190.

FIGS. 25A through D show further views of the configuration shown inFIG. 24C but wherein the recesses 200 are omitted clarity. Morespecifically, FIG. 25A is a view from the inferior side of the cup 150and shows that each fixation spike 156 points parallel to theinferior-superior axis of the cup 150 while each modular peg 158 pointsnormal to the exterior surface of the metal shell 22. As describedabove, FIG. 25B shows that the fixation spikes 156 are all in line withan axis through the centre of the cup 150 and passing midway between themodular pegs 158. FIG. 25C shows further alignment of the fixationspikes 156. FIG. 25D is a side view of the cup 150 showing that thefixation spikes 156 are parallel to the long axis of the modular pegs158. It is also evident from FIG. 25D that both the fixation spikes 156and the modular pegs 158 point parallel to the axis of insertion of thecup into the bone. Furthermore, FIG. 25D shows that the width of the rim160 around the periphery of the metal shell 22 is relatively narrow(only 1.5-2 mm thick) at the inferior side 202 of the cup 150 andrelatively wide (3-4 mm) around the supero-lateral side 204 of the cup150. This additional rim width is advantageous for support since it iscommon to have no bone covering the supero-lateral side 204 of the cup150.

FIG. 26 shows a part cross-sectional view through the modular pegs 158of FIG. 24C. Accordingly, it can be seen that the hole 192 in the fixingmeans 190 extends through the majority of the thickness of the metalshell 22 (which is at its thickest in this region opposite the wearzone) but terminates without penetrating all the way through. Thistherefore protects the polymer liner 24 (not shown) adjacent to thefixing means 190. As shown, each modular peg 158 includes a projection206 provided with an external screw thread for mating with the internalscrew thread 194 of the fixing means 190. It is also clear from FIG. 26that no spherical undercuts 110 (for polymer attachment) are provided inthe metal shell 22 directly opposite to the fixing means 190.

FIG. 27 shows a cross-sectional view similar to that shown in FIG. 26but showing the entire metal shell 22 of the acetabular cup 150,including several of the spherical cut-outs 110 for polymer attachment(arranged for illustrative purposes only). This figure clearly shows thethickness of the metal shell 22 being greatest in the centre of the cup150 and getting thinner towards the periphery of the cup 150. FIG. 27also shows that the long axis of each modular peg 158 diverges withrespect to the other. This arrangement has been chosen partly because itis desirable not to increase the thickness of the cup to make the pegsparallel and partly because diverging pegs provide good fixation in thebone. However, it will be understood that if the diverging peg werecylindrical it would not be possible to insert them securely into thebone (since this would require an undercut). However, with conical pegs158, as shown, it is possible to insert the cup in a straight line,without requiring an undercut. In the present embodiment, the conicalpegs 158 are disposed such that although they have diverging long axes,each outermost conical side is angled inwardly by 4 degrees fromparallel.

In another embodiment of the present invention (not shown) a prostheticcup may be provided with a truncated-bead lattice 152 as described aboveand shown in FIG. 17, but without any fixation means or modular pegs. Inthis case an array of fixation spikes 156 as described above are alsoprovided but in this case the spikes in the array vary in height and aresmallest towards the edge of the array and gradually increase in heightto the largest in the centre of the array. The array in this embodimentis generally of a circular disc shape which is located opposite to theintended wear zone (i.e. in the supero-lateral half of the cup).Furthermore, in this embodiment, the internal surface of the metal shellis provided with spherical cut-outs 110, as described above, but in thiscase the spherical cut-outs are all of a similar size and are evenlydistributed in a ring around the edge of the metal shell and over themajority of the rest of the metal shell but are not provided in theregion opposite to the rim of the shell or in the region opposite thearray of fixation spikes. These regions are provided free of cut-outsfor increased strength in these areas.

Alternative lattice structures to the truncated-bead lattice 152described above, are envisaged in accordance with embodiments of theinvention. FIGS. 28A through 29E are illustrative of one such latticestructure 230 which could be provided on an external surface of a metalshell of a prosthesis such as an acetabular cup. As before, the lattice230 is configured to provide the surface with a rough exterior to aidinitial fixation, a porous structure for bone in-growth and a pluralityof undercuts to allow bone to lock onto the surface.

More specifically, FIGS. 28A and B show an enlarged underneath view ofthe lattice 230. The lattice 230 includes a first series of posts 232that have a circular cross-section and a second series of posts 234 thathave a triple-lobed cross-section. When provided on an external surfaceof a prosthesis the posts 232 and 234 will extend normally of thesurface and will support mating ends (not shown) of a number of bridgingelements 236. In this embodiment, the circular posts 232 support matingends of six bridging elements 236. Each bridging element 236 extendsradially from a circular post 232 to a lobe 238 of one of thetriple-lobed posts 234. Each of the triple-lobed posts 234 is arrangedto support mating ends of three bridging elements 236, one extendingfrom each of its lobes 238. Accordingly, in this embodiment where eachcircular post 232 supports six bridging elements 236 and eachtriple-lobed post 234 supports three bridging elements 236, atessellating pattern is created with diamond-shaped gaps 240 providedbetween the bridging elements 236. As best shown in FIG. 2813, the posts232, 234 and bridging elements 236 are all have a relatively thickcross-section so as to allow for molten metal to easily flow into thestructure during manufacture of the lattice 230.

It will be understood that the lattice 230 described above not onlyallows bone in-growth through the gaps 240 between the bridging elements236 but also provide undercuts 242 in the regions underneath thebridging elements 236, between the posts 232, 234, into which bone cangrow to mechanically lock the implant in place.

FIGS. 29A through 29E show a top plan view of the lattice 230 of FIGS.28A and B. Although the posts 232, 234 are not clearly visible in theseviews, it will be understood that a circular post 232 is providedwherever six bridging elements 236 meet and a triple-lobed post 234 isprovided wherever three bridging elements 236 meet. As shown in thesefigures, a rough exterior is provided on the lattice 230 by theprovision of diamond and pyramid shaped cut-outs 242 in the exteriorsurface of the bridging elements 236. These cut-outs 242 create aplurality of sharp edges which can be presented to the bone during useto aid primary fixation of the implant.

FIG. 30A shows a perspective view of an acetabular cup prosthesis 250according to a further embodiment of the invention. The cup 250comprises a metal outer shell 252 and a polymer inner liner 254. Thepolymer inner liner 254 includes a first layer 256 which is formed byplacing polymer powder including vitamin E into the metal outer shell252 (which serves as an outer mould cavity) and cold compressionstamping the powder into the desired shape of the first layer 256. Itwill be noted that, in this embodiment, the first layer 256 is formedwith a recessed cavity 258 which is configured to receive a second layer260 of polymer powder as shown in FIG. 30B. Thus, after the moulding ofthe first layer 256, polymer powder (not including vitamin E) is placedin the cavity 258 and a second mould is employed to cold compress thepolymer powder into the second layer 260 forming a portion of thearticular surface layer of the cup 250. The first and second layers 256and 260 are then hot compression moulded to form a single solid cup 250before it is irradiated to cross-link the molecules in the second layer260. The cup 250 is then heated to below its melting point to encouragethe vitamin E in the first layer 256 to diffuse into the second layer260 to consume the free radicals therein and thereby minimise the riskof oxidation of the second layer 260. Thus, the cup 250 is formed with apartially cross-linked surface layer 260 in the intended wear zone,which is hoped to increase the wear resistance of the cup 250 duringuse.

FIG. 31 shows a perspective view of an acetabular cup prosthesis 260according to another embodiment of the invention. The cup 260 includeseach of the components described above in relation to FIGS. 30A and 30Band so like reference numerals will be employed as appropriate. The onlydifference between the cup 250 of FIGS. 30A and 30B and the present cup260 is that, as shown in FIG. 31, the second layer 260 is mouldedindependently of the cup 260 before being inserted into the recess 258.It will be understood that the step of hot compression moulding thefirst and second layers 256 and 260 is still performed in thisembodiment, along with the subsequent steps described above.

FIG. 32 shows a perspective view of an acetabular cup prosthesis 270according to a yet further embodiment of the invention. The cup 270 isessentially formed as described above in relation FIG. 31. However, inthis case, the second layer 272 is configured to form the whole of thearticular surface layer of the polymer liner 254. Thus, the first layer274 in this embodiment does not include a recess, as such, but rather isarranged to be thinner than the desired polymer liner 254 thickness soas to accommodate the second layer 272.

It will be understood that an advantage of employing the methodsdescribed above in relation to FIGS. 31 and 32 is that they ensure thatthe polymer powder of the second layer does not accumulate in the poleof the cup thereby producing a thicker than intended layer ofcross-linked polymer at the pole and a thinner than intended layer ofcross-linked polymer at the periphery of the cup (i.e. in the intendedwear zone).

In a further embodiment of the present invention, a polymer componentwas formed by blending Ticona GUR 1020 polyethylene resin powder withvarying amounts of antioxidant in the form of vitamin E (DSM dl alphaTocopherol). For comparison, a first sample was created with no vitaminE, a second sample was coated with 0.1% by weight of vitamin E and athird sample was coated with 2.0% by weight of vitamin E.

All three samples were packaged in special packets made from PET film,aluminium foil, adhesive layers and polyethylene film to keep thesamples separated from the atmosphere. Oxygen was removed from theinternal aspect of each of the packets after they were filled with thesamples by a sequence of vacuum, nitrogen gas flush, vacuum and finallysealing of the packets. Irradiation of each sample was performed bygamma irradiation at Isotron UK at a dose rate of less than 5 kGy perhour to provide a total dose of 100 kGy. Compression moulding of eachsample into consolidated blocks was performed using a bespoke mould at230 degrees C. at Orthoplastics UK. The consolidated blocks wereconditioned for 24 hours at 23 degrees C. prior to machining of testspecimens from the blocks according to FRM-PRD-003. Oxidation in theconsolidated specimens was measured using infrared spectroscopyaccording to ASTM F2102-01 (2001) and a graph of the results is shown inFIG. 33.

It can be seen from FIG. 33 that irradiating polyethylene resin withouta coating of antioxidant resulted in significant oxidation (greater than0.15%) of the bulk consolidated material, despite the irradiation beingcarried out in a reduced Oxygen environment. It is regarded in theorthopaedic industry that levels of oxidation above 0.1% (i.e. above0.100 on the BOI) are unacceptable for use as an orthopaedic implant.With 0.1% vitamin E added to the polyethylene, the bulk oxidation indexis reduced to an acceptable level of approximately 0.07%. Blending in2.0% vitamin E reduces the oxidation index even further, toapproximately 0.015%. Thus, it can be seen that using the method of thepresent invention, it is possible to produce cross-linked polymercomponents having an acceptable level of oxidation.

FIGS. 34A and 34B show a metal one-piece acetabular cup prosthesis 300according to a further embodiment of the present invention in which thecentre of the inner surface 302 has been displaced with respect to theouter surface 304 and a cut-out 306 is provided at an inferior edge.

In this particular embodiment, the inner centre has been displacedoutwards by 7 mm and downwards (i.e. inferiorly) by 2 mm. This allows a54 mm inner diameter (instead of the normal 50 mm inner diameterassociated with a standard 56 mm outer diameter cup). Accordingly, it ispossible to achieve a 2 mm inner diameter to outer diameter differenceso that a larger than normal femoral head (e.g. 54 mm rather than 50 mm)can be employed without increasing the size of the cup 300. Thistherefore helps to ensure better wear and load characteristics withoutrequiring the removal of any additional bone.

FIGS. 35A and 35B show a metal acetabular cup shell 310 having a rim 312around the whole the cup edge. The rim 312 is perforated with aplurality of holes 314 therethrough. As clearly shown in FIG. 35B, therim 312 is inset from the external surface 316 of the shell 310. Theshell 310 also comprises a threaded blind bore 318 located at the poleof the cup, on the interior surface 320.

As shown in FIGS. 36A and 36B, a polymer inner liner 322 is compressionmoulded in the shell 310 such that threads 324 of the polymer liner 322are formed through the holes 314 in the rim 312 and then moulded intothe polymer which is arranged to envelope the rim 312 to thereby stitchthe edge of the liner 322 to the shell 310. In addition, the polymerliner 322 is moulded into the threaded hole 31/8 of the shell 310 toprovide a macro fixation means and the inner surface 320 of the shell310 is roughened for micro-attachment of the polymer liner 322.

FIG. 37A shows an enlarged cross-sectional view of a spike 330 createdin an external surface 332 of a metal acetabular cup shell, inaccordance with an embodiment of the present invention. The spike 330 iscreated using e-beam sculpturing. Thus, the e-beam is initially focusedto melt a small droplet of metal on the surface 332 and then the e-beamis moved a small distance along the surface 332 to push the droplet ofmetal out of the melt pool 334 to form the adjacent spike 330. Thisprocess is repeated a number of times at different locations on thesurface 332 of the shell to create a series of spikes 330 forming arough exterior for initial fixation.

In certain embodiments, a vacuum plasma sprayed titanium coating 336 isthen applied to the spiky surface 332 to substantially cover the surface332, as illustrated in FIG. 37B. It will be understood that the titaniumcoating 336 provides the surface 332 with undercuts and a good pore sizeto promote bone in-growth for longer-term fixation.

It is also noted that the provision of the spikes 330 helps to ensurethat the titanium particles of the coating 336 are not dislodged byshear forces when the cup is inserted into a patient.

It will be appreciated by persons skilled in the art that variousmodifications may be made to the above embodiments without departingfrom the scope of the present invention. In particular, one or morefeatures from a first embodiment may be mixed and matched with one ormore features from a second or subsequent embodiment.

1.-56. (canceled)
 57. A prosthesis having an external surface providedwith two fixing means, each being configured for the exterior attachmentof a modular peg; and two conical modular pegs which extend in adirection normal to the external surface and which are configured suchthat each of their outer edges are parallel or converging, when in use.58. The prosthesis of claim 57 wherein each fixing means is constitutedby a cavity having an internal screw-thread.
 59. The prosthesis of claim58 wherein each cavity has a closed end to prevent debris or tissue frompassing through the external surface of the prosthesis and causingdamage within.
 60. The prosthesis of claim 58 wherein a filling isprovided to substantially fill the cavity of the fixing means if themodular peg is not required.
 61. The prosthesis of claim 60 wherein thefilling is in the form of a grub screw having an external screw threadto mate with that of the fixing means and a relatively small recess inits top surface for location of a tool to selectively remove thefilling.
 62. The prosthesis of claim 57 wherein each modular pegterminates with a rounded tip.
 63. The prosthesis of claim 57 whereineach modular peg includes one or more notches to aid grip when attachingthem to the fixing means.
 64. The prosthesis of claim 57 wherein theprosthesis is configured as an acetabular cup.
 65. The prosthesis ofclaim 64 wherein the acetabular cup comprises a metal outer shell and apolymer inner liner, the external surface of the prosthesis beingconstituted by the external surface of the metal outer shell.
 66. Theprosthesis of claim 64 wherein the fixing means is located on the mostproximal region of the cup when orientated ready for insertion.